BACT/ALERT® FA PLUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 03573026596057), received between Jul 17, 2017 and Jun 12, 2025 — classified as 4 injuries, 122 malfunctions.

The most frequently reported specific device problem is “Cross Reactivity” (60 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 19, 2024Open, Classified

   If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.

   Z-2456-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Cross Reactivity; Cross Reactivity

  PRODUCT DESCRIPTION: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. COMPLAINT DESCRIPTION: A CUSTOMER IN CHILE COMPLAINED ABOUT FALSE POSITIVE INTERFERENCE USING THE BIOFIRE BCID2 PANEL. THE CUSTOMER SAID THAT THEY HAD TESTED ONE PATIENT'S SAMPLE USING BACT/ALERT FA PLUS (PLASTIC) REF 410851 LOT 0004102998 IN CONJUNCTION WITH THEIR BACT/ALERT SYSTEM AND THAT A POSITIVE SIGNAL WAS OBTAINED. THE CUSTOMER SAID THAT THE BOTTLE CONTENTS WERE THEN TESTED USING THE BCID2 PANEL WITH RESULT OF STAPHYLOCOCCUS SPP., STAPHYLOCOCCUS EPIDERMIDIS, ENTEROBACTERALES, AND SERRATIA MARCESCENS. THE CUSTOMER REPORTED THAT S. MARCESCENS WAS NOT RECOVERED IN CULTURE; ONLY S. EPIDERMIDIS GREW. THE COMPLAINT ASSOCIATED WITH BIOFIRE BCID2 PANEL HAS BEEN RECORDED UNDER (B)(6). THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE CONCERNED PATIENT'S STATE OF HEALTH. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196559 ↗
• MalfunctionJun 3, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN ARGENTINA NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE BCID RESULTS ASSOCIATED WITH 3 SAMPLES TESTED IN THE BACT/ALERT FA PLUS (PLASTIC) 100 BTLS -REF. 410851, LOT 0004102408. SUMMARY: BCID2: NOT PROVIDED BUT FALSE POSITIVE FOR S. MARCESCENS. SAMPLE: POSITIVE BLOOD CULTURE. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE PHYSICIAN SHOULD USE ALL INFORMATION AVAILABLE ON THE PATIENT TO INTERPRET THE BIOFIRE® FILMARRAY® BCID2 PANEL RESULTS ACCORDINGLY. THE PRESENCE OF CONTAMINATING NUCLEIC ACID FROM NON-VIABLE MICROORGANISM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22135760 ↗
• MalfunctionJun 3, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN ARGENTINA NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE BCID RESULTS ASSOCIATED WITH 3 SAMPLES TESTED IN THE BACT/ALERT FA PLUS (PLASTIC) 100 BTLS -REF. (B)(4), LOT 0004102408. SUMMARY: BCID2: NOT PROVIDED BUT FALSE POSITIVE FOR S. MARCESCENS. SAMPLE: POSITIVE BLOOD CULTURE. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE PHYSICIAN SHOULD USE ALL INFORMATION AVAILABLE ON THE PATIENT TO INTERPRET THE BIOFIRE® FILMARRAY® BCID2 PANEL RESULTS ACCORDINGLY. THE PRESENCE OF CONTAMINATING NUCLEIC ACID FROM NON-VIABLE MICROORGANISM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22135759 ↗
• MalfunctionJun 3, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN ARGENTINA NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE BCID RESULTS ASSOCIATED WITH 3 SAMPLES TESTED IN THE BACT/ALERT FA PLUS (PLASTIC) 100 BTLS -REF. 410851, LOT 0004102408. SUMMARY: BCID2: NOT PROVIDED BUT FALSE POSITIVE FOR S. MARCESCENS. SAMPLE: POSITIVE BLOOD CULTURE. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE PHYSICIAN SHOULD USE ALL INFORMATION AVAILABLE ON THE PATIENT TO INTERPRET THE BIOFIRE® FILMARRAY® BCID2 PANEL RESULTS ACCORDINGLY. THE PRESENCE OF CONTAMINATING NUCLEIC ACID FROM NON-VIABLE MICROORGANISM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22135753 ↗
• MalfunctionMay 28, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE. BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION OF THE ISSUE. A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE BIOFIRE DETECTION FOR SERRATIA MARCESCENS USING THE BIOFIRE BCID2 PANEL FOR TWO (2) PATIENTS WHEN TESTING POSITIVE SAMPLES OF BACT/ALERT FA PLUS (PLASTIC) 100 BTLS - 410851 (LOT#: 0004102946). THIS REPORT IS FOR PATIENT (B)(6); A SECOND REPORT WILL BE SUBMITTED FOR PATIENT (B)(6). PATIENT (B)(6): PATIENT AGE AND GENDER = NOT PROVIDED. PATIENT DIAGNOSIS = NOT PROVIDED. BOTTLE ID = NOT PROVIDED. GRAM STAIN = GRAM POSITIVE COCCI. SUBCULTURE = STAPHYLOCOCCUS CAPITIS (IDENTIFIED BY VITEK 2 RESULT). BCID 2 PANEL RESULT = STAPHYLOCOCCUS SPP., STAPHYLOCOCCUS EPIDERMIDIS, ENTEROBACTERALES, SERRATIA MARCESCENS. NEITHER PATIENT WAS AFFECTED OR HARMED BY THE FALSE POSITIVE S. MARCESCENS RESULT. FOR PATIENT (B)(6) ONLY S. EPIDERMIDIS WAS REPORTED TO THE PHYSICIAN. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22093953 ↗
• MalfunctionMay 28, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN REPUBLIC OF KOREA NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE BIOFIRE DETECTION FOR SERRATIA MARCESCENS USING THE BIOFIRE BCID2 PANEL FOR TWO (2) PATIENTS WHEN TESTING POSITIVE SAMPLES OF BACT/ALERT FA PLUS (PLASTIC) 100 BTLS - 410851 (LOT# 0004102946). THIS REPORT IS FOR PATIENT 2; A SECOND REPORT WILL BE SUBMITTED FOR PATIENT 1. PATIENT 2: PATIENT AGE AND GENDER = NOT PROVIDED, PATIENT DIAGNOSIS = NOT PROVIDED, BOTTLE ID = NOT PROVIDED, GRAM STAIN = NOT PROVIDED, SUBCULTURE = NOT PROVIDED, BLOOD CULTURE RESULT = NEGATIVE, BCID 2 PANEL RESULT = ENTEROBACTERALES, SERRATIA MARCESCENS (REPEATED - TWICE). NEITHER PATIENT WAS AFFECTED OR HARMED BY THE FALSE POSITIVE S. MARCESCENS RESULT. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO ANY DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR THE CONCERNED PATIENT. AN INVESTIGATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22093952 ↗
• MalfunctionMay 23, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN INDIA NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS WITH THE BCID2 PANEL (BIOFIRE) FOR SAMPLES FROM SIX (6) PATIENTS AFTER THE SAMPLES WERE INCUBATED IN BACT/ALERT FA PLUS (PLASTIC) 100 BTLS (REF (B)(4), LOT 0004102956, EXPIRATION DATE 17-SEP-2025). THE CUSTOMER REPORTED THE BCID2 GAVE POSITIVE RESULTS FOR SERRATIA MARCESCENS, BUT S. MARCESCENS WAS NOT RECOVERED. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM, THE BOTTLE FUNCTIONED AS INTENDED IN SIGNALING POSITIVE FOR THE ORGANISM THAT WAS PRESENT. THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077478 ↗
• MalfunctionMay 14, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN ARGENTINA NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE SERRATIA MARCESCENS RESULTS DURING BCID2 TESTING FOR (B)(4) PATIENTS WHOSE SAMPLES WERE ASSOCIATED WITH BACT/ALERT FA PLUS (PLASTIC) 100 BTLS -REF. (B)(4), LOT 0004102408. GLOBAL CUSTOMER SERVICE REQUESTED PATIENT INFORMATION, GRAM STAIN RESULTS, AND EXPECTED IDENTIFICATION. SUMMARY: -- BCID2: NOT PROVIDED BUT FALSE POSITIVE FOR S. MARCESCENS. -- GRAM: UNKNOWN. -- SAMPLE: POSITIVE BLOOD CULTURE. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE PHYSICIAN SHOULD USE ALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022328 ↗
• MalfunctionMay 14, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN ARGENTINA NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE SERRATIA MARCESCENS RESULTS DURING BCID2 TESTING FOR FIVE PATIENTS WHOSE SAMPLES WERE ASSOCIATED WITH BACT/ALERT FA PLUS (PLASTIC) 100 BTLS -REF. 410851, LOT 0004102408. GLOBAL CUSTOMER SERVICE REQUESTED PATIENT INFORMATION, GRAM STAIN RESULTS, AND EXPECTED IDENTIFICATION. SUMMARY: BCID2: NOT PROVIDED BUT FALSE POSITIVE FOR S. MARCESCENS GRAM: UNKNOWN. SAMPLE: POSITIVE BLOOD CULTURE. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE PHYSICIAN SHOULD USE ALL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022326 ↗
• MalfunctionMay 14, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN ARGENTINA NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE SERRATIA MARCESCENS RESULTS DURING BCID2 TESTING FOR FIVE PATIENTS WHOSE SAMPLES WERE ASSOCIATED WITH BACT/ALERT FA PLUS (PLASTIC) 100 BTLS -REF. 410851, LOT 0004102408. GLOBAL CUSTOMER SERVICE REQUESTED PATIENT INFORMATION, GRAM STAIN RESULTS, AND EXPECTED IDENTIFICATION. SUMMARY: -- BCID2: NOT PROVIDED BUT FALSE POSITIVE FOR S. MARCESCENS. -- GRAM: UNKNOWN. -- SAMPLE: POSITIVE BLOOD CULTURE. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE PHYSICIAN SHOULD USE ALL IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022316 ↗
• MalfunctionMay 14, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN ARGENTINA NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE SERRATIA MARCESCENS RESULTS DURING BCID2 TESTING FOR FIVE PATIENTS WHOSE SAMPLES WERE ASSOCIATED WITH BACT/ALERT FA PLUS (PLASTIC) 100 BTLS -REF. (B)(4), LOT 0004102408. GLOBAL CUSTOMER SERVICE REQUESTED PATIENT INFORMATION, GRAM STAIN RESULTS, AND EXPECTED IDENTIFICATION. SUMMARY: -- BCID2: NOT PROVIDED BUT FALSE POSITIVE FOR S. MARCESCENS. -- GRAM: UNKNOWN. -- SAMPLE: POSITIVE BLOOD CULTURE. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE PHYSICIAN SHOULD USE ALL IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022312 ↗
• MalfunctionMay 14, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN ARGENTINA NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE SERRATIA MARCESCENS RESULTS DURING BCID2 TESTING FOR FIVE PATIENTS WHOSE SAMPLES WERE ASSOCIATED WITH BACT/ALERT FA PLUS (PLASTIC) 100 BTLS -REF. 410851, LOT 0004102408. GLOBAL CUSTOMER SERVICE REQUESTED PATIENT INFORMATION, GRAM STAIN RESULTS, AND EXPECTED IDENTIFICATION. SUMMARY: -- BCID2: NOT PROVIDED BUT FALSE POSITIVE FOR S. MARCESCENS. -- GRAM: UNKNOWN. -- SAMPLE: POSITIVE BLOOD CULTURE. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE PHYSICIAN SHOULD USE ALL IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022309 ↗
• MalfunctionMay 13, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN INDIA NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED A FALSE POSITIVE RESULT FOR SERRATIA MARCESCENS WITH THE BCID2 PANEL (BIOFIRE) FOR A SAMPLE FROM ONE PATIENT AFTER THE SAMPLE WAS INCUBATED IN BACT/ALERT FA PLUS (PLASTIC) 100 BTLS (REF 410851, LOT 0004102956). THE CUSTOMER REPORTED THE BCID2 GAVE A POSITIVE RESULT FOR SERRATIA MARCESCENS, BUT S. MARCESCENS WAS NOT RECOVERED. GRAM STAINING SHOWED GRAM-NEGATIVE BACILLI AND SUBCULTURE GREW OXIDASE-POSITIVE NON-FERMENTING GRAM-NEGATIVE BACILLI. PATIENT 1: PATIENT 77 YEAR OLD FEMALE. PATIENT DIAGNOSIS: ARDS (ACUTE RESPIRATORY DISTRESS SYNDROME), PULMONARY EDEMA. BOTTLE ID = ARCLD4T4. GRAM STAIN = GRAM NEGATIVE BACILLI (THIN GRAM-NEGATIVE BACILLI). SUBCULTURE = SERRATIA MARCESCENS WAS NOT GROWN IN CULTURE. CULTURE GREW OXIDASE-POSITIVE NON FERMENTING GRAM NEGATIVE BACILLI IDENTIFIED BY VITEK 2 AS RALSTONIA INSIDIOSA BCID2 RESULTS = DETECTED FOR: ENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010105 ↗
• MalfunctionMay 9, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN THE REPUBLIC OF KOREA NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS FOR THE BCID2 PANEL (BIOFIRE) FOR SAMPLES FROM FOUR (4) DIFFERENT PATIENTS AFTER THE SAMPLES WERE INCUBATED IN BACT/ALERT FA PLUS (PLASTIC) 100 BTLS (REF 410851, LOT 0004102946). THE CUSTOMER REPORTED THAT FOR BOTH SAMPLES, THE BCID2 GAVE A POSITIVE RESULT FOR SERRATIA MARCESCENS, BUT MICROBIAL IDENTIFICATION TESTING FROM THE SAME SAMPLES DID NOT DETECT SERRATIA MARCESCENS. THE CUSTOMER DECLINED TO SHARE ANY INFORMATION REGARDING THE IDENTIFICATION OF THE ORGANISM(S) RECOVERED, OR THE PATIENTS' DIAGNOSES AND TREATMENT. HOWEVER, THE CUSTOMER STATED THAT THE FALSE POSITIVE RESULT FOR S. MARCESCENS WITH THE BCID2 WAS NOT REPORTED TO THE CLINICIANS, SO THERE WAS NO IMPACT TO PATIENT CARE. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. FROM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995022 ↗
• MalfunctionMay 9, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN THE REPUBLIC OF KOREA NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS FOR THE BCID2 PANEL (BIOFIRE) FOR SAMPLES FROM FOUR (4) DIFFERENT PATIENTS AFTER THE SAMPLES WERE INCUBATED IN BACT/ALERT FA PLUS (PLASTIC) 100 BTLS (REF 410851, LOT 0004102946). THE CUSTOMER REPORTED THAT FOR BOTH SAMPLES, THE BCID2 GAVE A POSITIVE RESULT FOR SERRATIA MARCESCENS, BUT MICROBIAL IDENTIFICATION TESTING FROM THE SAME SAMPLES DID NOT DETECT SERRATIA MARCESCENS. THE CUSTOMER DECLINED TO SHARE ANY INFORMATION REGARDING THE IDENTIFICATION OF THE ORGANISM(S) RECOVERED, OR THE PATIENTS' DIAGNOSES AND TREATMENT. HOWEVER, THE CUSTOMER STATED THAT THE FALSE POSITIVE RESULT FOR S. MARCESCENS WITH THE BCID2 WAS NOT REPORTED TO THE CLINICIANS, SO THERE WAS NO IMPACT TO PATIENT CARE. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. FROM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995016 ↗
• MalfunctionMay 9, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN THE REPUBLIC OF KOREA NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS FOR THE BCID2 PANEL (BIOFIRE) FOR SAMPLES FROM FOUR (4) DIFFERENT PATIENTS AFTER THE SAMPLES WERE INCUBATED IN BACT/ALERT FA PLUS (PLASTIC) 100 BTLS (REF 410851, LOT 0004102946). THE CUSTOMER REPORTED THAT FOR BOTH SAMPLES, THE BCID2 GAVE A POSITIVE RESULT FOR SERRATIA MARCESCENS, BUT MICROBIAL IDENTIFICATION TESTING FROM THE SAME SAMPLES DID NOT DETECT SERRATIA MARCESCENS. THE CUSTOMER DECLINED TO SHARE ANY INFORMATION REGARDING THE IDENTIFICATION OF THE ORGANISM(S) RECOVERED, OR THE PATIENTS' DIAGNOSES AND TREATMENT. HOWEVER, THE CUSTOMER STATED THAT THE FALSE POSITIVE RESULT FOR S. MARCESCENS WITH THE BCID2 WAS NOT REPORTED TO THE CLINICIANS, SO THERE WAS NO IMPACT TO PATIENT CARE. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. FROM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995015 ↗
• MalfunctionMay 9, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN THE REPUBLIC OF KOREA NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS FOR THE BCID2 PANEL (BIOFIRE) FOR SAMPLES FROM FOUR (4) DIFFERENT PATIENTS AFTER THE SAMPLES WERE INCUBATED IN BACT/ALERT FA PLUS (PLASTIC) 100 BTLS (REF 410851, LOT 0004102946). THE CUSTOMER REPORTED THAT FOR BOTH SAMPLES, THE BCID2 GAVE A POSITIVE RESULT FOR SERRATIA MARCESCENS, BUT MICROBIAL IDENTIFICATION TESTING FROM THE SAME SAMPLES DID NOT DETECT SERRATIA MARCESCENS. THE CUSTOMER DECLINED TO SHARE ANY INFORMATION REGARDING THE IDENTIFICATION OF THE ORGANISM(S) RECOVERED, OR THE PATIENTS' DIAGNOSES AND TREATMENT. HOWEVER, THE CUSTOMER STATED THAT THE FALSE POSITIVE RESULT FOR S. MARCESCENS WITH THE BCID2 WAS NOT REPORTED TO THE CLINICIANS, SO THERE WAS NO IMPACT TO PATIENT CARE. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. FROM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995010 ↗
• MalfunctionApr 17, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN REPUBLIC OF KOREA NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE BIOFIRE INTERFERENCE FOR SERRATIA MARCESCENS THAT WAS DETECTED USING THE BIOFIRE BCID2 PANEL FOR FOUR (4) PATIENTS/SAMPLE IN ASSOCIATION WITH BACT/ALERT FA PLUS (PLASTIC) 100 BTLS - 410851 (LOT# 0004102946). PATIENT 1: PATIENT 66-YEAR-OLD FEMALE BOTTLE ID = NOT PROVIDED, GRAM STAIN = NOT PROVIDED, SUBCULTURE = BAP ¿ GROWTH, MAC ¿ NO GROWTH, BCID2 RESULTS = CANDIDA PARAPSILOSIS, CANDIDA TROPICALIS, SERRATIA MARCESCENS, IDENTIFICATION = CANDIDA BY MALDI-TOF (VITEK MS PRIME). PATIENT 2: PATIENT 50-YEAR-OLD FEMALE, BOTTLE ID = NOT PROVIDED, GRAM STAIN = NOT PROVIDED, SUBCULTURE = BAP & MAC ¿ GROWTH WITH PINK COLONY, BCID2 RESULTS = ESCHERICHIA COLI, SERRATIA MARCESCENS, ¿IDENTIFICATION = ESCHERICHIA COLI ONLY BY MALDI-TOF (VITEK MS PRIME). PATIENT 3: PATIENT 66-YEAR-OLD FEMALE, BOTTLE ID = NOT PROVIDED, GRAM STAIN = NOT PROVIDED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857176 ↗
• MalfunctionApr 17, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN REPUBLIC OF KOREA NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE BIOFIRE INTERFERENCE FOR SERRATIA MARCESCENS THAT WAS DETECTED USING THE BIOFIRE BCID2 PANEL FOR FOUR (4) PATIENTS/SAMPLE IN ASSOCIATION WITH BACT/ALERT FA PLUS (PLASTIC) 100 BTLS - 410851 (LOT# 0004102946). PATIENT 1: PATIENT 66-YEAR-OLD FEMALE BOTTLE ID = NOT PROVIDED GRAM STAIN = NOT PROVIDED SUBCULTURE = BAP ¿ GROWTH, MAC ¿ NO GROWTH. BCID2 RESULTS = CANDIDA PARAPSILOSIS, CANDIDA TROPICALIS, SERRATIA MARCESCENS IDENTIFICATION = CANDIDA BY MALDI-TOF (VITEK MS PRIME). PATIENT 2: PATIENT 50-YEAR-OLD FEMALE BOTTLE ID = NOT PROVIDED GRAM STAIN = NOT PROVIDED SUBCULTURE = BAP & MAC ¿ GROWTH WITH PINK COLONY BCID2 RESULTS = ESCHERICHIA COLI, SERRATIA MARCESCENS. IDENTIFICATION = ESCHERICHIA COLI ONLY BY MALDI-TOF (VITEK MS PRIME). PATIENT 3: PATIENT 66-YEAR-OLD FEMALE, BOTTLE ID = NOT PROVIDED, GRAM STAIN = NOT PROVIDED, SUBCULTU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855810 ↗
• MalfunctionApr 17, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN REPUBLIC OF KOREA NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE BIOFIRE INTERFERENCE FOR SERRATIA MARCESCENS THAT WAS DETECTED USING THE BIOFIRE BCID2 PANEL FOR FOUR (4) PATIENTS/SAMPLE IN ASSOCIATION WITH BACT/ALERT FA PLUS (PLASTIC) 100 BTLS - 410851 (LOT# 0004102946). PATIENT 1: PATIENT 66-YEAR-OLD FEMALE BOTTLE ID = NOT PROVIDED, GRAM STAIN = NOT PROVIDED, SUBCULTURE = BAP ¿ GROWTH, MAC ¿ NO GROWTH, BCID2 RESULTS = CANDIDA PARAPSILOSIS, CANDIDA TROPICALIS, SERRATIA MARCESCENS, IDENTIFICATION = CANDIDA BY MALDI-TOF (VITEK MS PRIME). PATIENT 2: PATIENT 50-YEAR-OLD FEMALE BOTTLE ID = NOT PROVIDED, GRAM STAIN = NOT PROVIDED, SUBCULTURE = BAP & MAC ¿ GROWTH WITH PINK COLONY, BCID2 RESULTS = ESCHERICHIA COLI, SERRATIA MARCESCENS, IDENTIFICATION = ESCHERICHIA COLI ONLY BY MALDI-TOF (VITEK MS PRIME). PATIENT 3: PATIENT 66-YEAR-OLD FEMALE BOTTLE ID = NOT PROVIDED, GRAM STAIN = NOT PROVIDED, SUB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855479 ↗
• MalfunctionApr 17, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN REPUBLIC OF KOREA NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE BIOFIRE INTERFERENCE FOR SERRATIA MARCESCENS THAT WAS DETECTED USING THE BIOFIRE BCID2 PANEL FOR FOUR (4) PATIENTS/SAMPLE IN ASSOCIATION WITH BACT/ALERT FA PLUS (PLASTIC) 100 BTLS - 410851 (LOT# 0004102946). PATIENT 1: PATIENT 66-YEAR-OLD FEMALE, BOTTLE ID = NOT PROVIDED, GRAM STAIN = NOT PROVIDED, SUBCULTURE = BAP ¿ GROWTH, MAC ¿ NO GROWTH, BCID2 RESULTS = CANDIDA PARAPSILOSIS, CANDIDA TROPICALIS, SERRATIA MARCESCENS, IDENTIFICATION = CANDIDA BY MALDI-TOF (VITEK MS PRIME). PATIENT 2: PATIENT 50-YEAR-OLD FEMALE, BOTTLE ID = NOT PROVIDED, GRAM STAIN = NOT PROVIDED, SUBCULTURE = BAP & MAC ¿ GROWTH WITH PINK COLONY, BCID2 RESULTS = ESCHERICHIA COLI, SERRATIA MARCESCENS, IDENTIFICATION = ESCHERICHIA COLI ONLY BY MALDI-TOF (VITEK MS PRIME). PATIENT 3: PATIENT 66-YEAR-OLD FEMALE, BOTTLE ID = NOT PROVIDED, GRAM STAIN = NOT PROVIDED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853758 ↗
• MalfunctionApr 16, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN CHILE NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT FA PLUS (PLASTIC) 100 BTLS -REF. 410851, LOT 0004102946. SUMMARY: BCID2: NOT PROVIDED BUT FALSE POSITIVE FOR S. MARCESCENS. GRAM: GRAM NEGATIVE BACILLI. SAMPLE: POSITIVE BLOOD CULTURE. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE PHYSICIAN SHOULD USE ALL INFORMATION AVAILABLE ON THE PATIENT TO INTERPRET THE BIOFIRE® FILMARRAY® BCID2 PANEL RESULTS ACCORDINGLY. THE PRESENCE OF CONTAMINATING NUCLEIC ACID FROM NON-VIABLE MICROORGANISMS IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21847927 ↗
• MalfunctionMar 19, 2025Cross Reactivity; Cross Reactivity

  PRODUCT DESCRIPTION: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED ABOUT FALSE POSITIVE INTERFERENCE USING THE BIOFIRE BCID2 PANEL. THE CUSTOMER SAID THAT THEY HAD TESTED THREE SAMPLES USING BACT/ALERT FA PLUS (PLASTIC) REF (B)(4) LOT 0004102996 IN CONJUNCTION WITH THEIR BACT/ALERT SYSTEM AND THAT POSITIVE SIGNAL WERE OBTAINED. THE CUSTOMER SAID THAT THE BOTTLES CONTENTS WERE THEN TESTED USING THE BCID2 PANEL WITH RESULTS OF SERRATIA MARCESCENS. THE CUSTOMER REPORTED THAT S. MARCESCENS WAS NOT RECOVERED IN CULTURE. THE CUSTOMER SAID THAT REPEATING TESTS WERE PERFORMED ON THE BCID2 PANEL ON ALL 3 SPECIMENS AND S. MARCESCENS WAS NOT DETECTED. THE COMPLAINT ASSOCIATED WITH BIOFIRE BCID2 PANEL HAS BEEN RECORDED UNDER (B)(4). THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE CONCERNED PATIENT'S STATE OF HEALTH. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21640821 ↗
• MalfunctionJan 28, 2025Cross Reactivity; Cross Reactivity

  PRODUCT DESCRIPTION: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF HAVING EXPERIENCED A FALSE POSITIVE RESULT FOR PSEUDOMONAS AERUGINOSA WHEN TESTING A BLOOD SAMPLE INCUBATED IN A BACT/ALERT FA PLUS (PLASTIC) BOTTLE (REF 410851, LOT 0004102942) USING BIOFIRE BCID2 PANEL. THE CUSTOMER STATED THAT GRAM STAIN WAS PERFORMED THAT CONFIRMED THE PRESENCE OF GRAM-NEGATIVE BACILLI. THE CUSTOMER SAID THEY HAD TESTED THE SAMPLE FROM THE BACT/ALERT BOTTLE USING BCID2 PANEL AND THAT E. COLI, K. PNEUMONIAE GROUP AND P. AERUGINOSA WERE DETECTED. THE CUSTOMER REPORTED THAT THEY HAD SUBCULTURED THE SAMPLE ON BAP AND MACCONKEY PLATES AND THAT THEY HAD OBSERVED COLONIES OF E. COLI AND K. PNEUMONIAE GROUP WHEREAS THEY WERE UNABLE TO RECOVER PSEUDOMONAS AERUGINOSA FROM CULTURE. THE CUSTOMER ALSO TESTED THE SAMPLE FOR IDENTIFICATION TEST USING VITEK MS TECHNIQUE AND THAT THEY HAD IDENTIFIED TWO (2) TYPES OF E. COLI AND K. PN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21253404 ↗
• MalfunctionDec 27, 2024Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT OF A FALSE POSITIVE RESULTS FOR CANDIDA TROPICALIS FOR THE BCID2 PANEL FOR TWO PATIENTS AFTER THE SAMPLES WERE INCUBATED IN BACT/ALERT FA PLUS (PLASTIC) BOTTLES (REF (B)(4), LOT 0004102816). PATIENT 1: AGE = 8. PATIENT 2: AGE = 23. THE RESULT FOR THE BCID2 PANEL WAS CANDIDA PARAPSILOSIS AND CANDIDA TROPICALIS DETECTED FOR BOTH PATIENTS. IN THE CULTURES THERE WAS DEVELOPMENT OF C. PARAPSILOSIS, BUT THERE WAS NO DEVELOPMENT OF C. TROPICALIS. THE CUSTOMER RECOVERED THE TRUE ORGANISM (CANDIDA PARAPSILOSIS) THAT WAS IN THE PATIENTS' SAMPLES, AS WELL AS DEAD DNA DETECTED FOR CANDIDA TROPICALIS ON THE BIOFIRE BCID2 PANEL. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM, THE BOTTLE FUNCTIONED AS INTENDED IN SIGNALING POSITIVE FOR THE ORGANISM THAT WAS PRESENT. THE BOTTLE WAS SIGNAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027251 ↗