BACT/ALERT® PF PLUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 03573026596095), received between May 4, 2017 and Jun 5, 2025 — classified as 2 injuries, 122 malfunctions.

The most frequently reported specific device problem is “Contamination” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE. BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. DESCRIPTION OF THE ISSUE. A CUSTOMER IN UNITED STATES NOTIFIED BIOMÉRIEUX OF BIOFIRE INTERFERENCE FOR SERRATIA MARCESCENS THAT WAS DETECTED USING THE BIOFIRE BCID2 PANEL FOR ONE (1) PATIENT IN ASSOCIATION WITH BACT/ALERT PF PLUS (PLASTIC) 100 BTLS - 410853 (LOT#: 0004102452). CUSTOMER REPORTS THEY HAD A PATIENT THAT HAD A DETECTED S. MARCESCENS THAT WAS REPORTED. THERE WAS NO GRAM NEGATIF RESULT IN THE GRAM STAIN, AND NO S. MARCESCENS ISOLATED IN CULTURE. THEY SAID IT WAS A FAILURE IN THEIR PROCESS DUE TO REPORTING RESULT WITHOUT MATCHING GRAM STAIN. PATIENT WAS A LITTLE UNDER 1 MONTH OLD AT TIME OF TESTING AND IS FEMALE. RESULTS REPORTED TO PHYSICIAN: THE INITIAL BCID RESULT OF SERRATIA MARCESCENS [AND S. AUREUS (NO METHICILLIN RESISTANCE)] WAS REPORTED OUT TO THE PHYSICIAN AS WAS THEIR REPORT ONCE THEY WERE UNABLE TO ISOLATE THE SERRATIA. BCID2 INFORMATION: SN: (B)(6)1, LOT#: 3D3C24/1235724, INSTRUMENT SN: (B)(6), ORGANISMS DETECTED: STAPHYLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149798 ↗
• MalfunctionApr 25, 2025Cross Reactivity; Cross Reactivity

  PRODUCT DESCRIPTION: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED ABOUT FALSE POSITIVE INTERFERENCE DURING USE OF THE BIOFIRE BCID2 PANEL. THE CUSTOMER SAID THAT THEY HAD TESTED THREE (3) PATIENT'S SAMPLES USING BACT/ALERT PF PLUS (PLASTIC) CULTURE BOTTLES (REF: (B)(4), LOT: 0004102964) IN CONJUNCTION WITH THEIR BACT/ALERT SYSTEM AND THAT A POSITIVE SIGNAL WAS OBTAINED FOR EACH BOTTLE. THE CUSTOMER SAID THAT THE BOTTLES CONTENTS WERE THEN TESTED USING THE BCID2 PANEL WITH RESULTS OF SERRATIA MARCESCENS. PATIENT (B)(6), 84 YO FEMALE, BCID2 RESULT(S) REPORTED - POSITIVE BLOOD CULTURE WITH STAPHYLOCOCCUS EPIDERMIDIS MECA/C AND SERRATIA. ALL TESTING PERFORMED ON THE SAMPLE AND THE RESULTS. PLATED MEDIA: NO GN SEEN ON GRAM STAIN, NO GROWTH OF SERRATIA RECOVERED REPEAT BCID: ONLY ORGANISM REPEATED WAS THE STAPH EPI. PATIENT (B)(6), 3 WKO, MALE, BCID2 RESULT(S) REPORTED - POSITIVE BLOOD CULTURE WITH STAPHYLOCOCCUS EPIDERMIDIS WITH MECA/C. ALL T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21907442 ↗
• MalfunctionApr 25, 2025Cross Reactivity; Cross Reactivity

  PRODUCT DESCRIPTION: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED ABOUT FALSE POSITIVE INTERFERENCE DURING USE OF THE BIOFIRE BCID2 PANEL. THE CUSTOMER SAID THAT THEY HAD TESTED THREE (3) PATIENT'S SAMPLES USING BACT/ALERT PF PLUS (PLASTIC) CULTURE BOTTLES (REF (B)(4), LOT 0004102964) IN CONJUNCTION WITH THEIR BACT/ALERT SYSTEM AND THAT A POSITIVE SIGNAL WAS OBTAINED FOR EACH BOTTLE. THE CUSTOMER SAID THAT THE BOTTLES CONTENTS WERE THEN TESTED USING THE BCID2 PANEL WITH RESULTS OF SERRATIA MARCESCENS. PATIENT 1 84 YO FEMALE. BCID2 RESULT(S) REPORTED - POSITIVE BLOOD CULTURE WITH STAPHYLOCOCCUS EPIDERMIDIS MECA/C AND SERRATIA. ALL TESTING PERFORMED ON THE SAMPLE AND THE RESULTS. --PLATED MEDIA: NO GN SEEN ON GRAM STAIN, NO GROWTH OF SERRATIA RECOVERED. --REPEAT BCID: ONLY ORGANISM REPEATED WAS THE STAPH EPI. PATIENT 2 3 WKO, MALE. BCID2 RESULT(S) REPORTED - POSITIVE BLOOD CULTURE WITH STAPHYLOCOCCUS EPIDERMIDIS WITH MECA/C. ALL TESTING PE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21907437 ↗
• MalfunctionApr 25, 2025Cross Reactivity; Cross Reactivity

  PRODUCT DESCRIPTION. BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. COMPLAINT DESCRIPTION. A CUSTOMER IN THE UNITED STATES COMPLAINED ABOUT FALSE POSITIVE INTERFERENCE DURING USE OF THE BIOFIRE BCID2 PANEL. THE CUSTOMER SAID THAT THEY HAD TESTED THREE (3) PATIENT'S SAMPLES USING BACT/ALERT PF PLUS (PLASTIC) CULTURE BOTTLES (REF 410853, LOT 0004102964) IN CONJUNCTION WITH THEIR BACT/ALERT SYSTEM AND THAT A POSITIVE SIGNAL WAS OBTAINED FOR EACH BOTTLE. THE CUSTOMER SAID THAT THE BOTTLES CONTENTS WERE THEN TESTED USING THE BCID2 PANEL WITH RESULTS OF SERRATIA MARCESCENS. PATIENT 1 84 YO FEMALE BCID2 RESULT(S) REPORTED - POSITIVE BLOOD CULTURE WITH STAPHYLOCOCCUS EPIDERMIDIS MECA/C AND SERRATIA ALL TESTING PERFORMED ON THE SAMPLE AND THE RESULTS. --PLATED MEDIA: NO GN SEEN ON GRAM STAIN, NO GROWTH OF SERRATIA RECOVERED --REPEAT BCID: ONLY ORGANISM REPEATED WAS THE STAPH EPI. PATIENT 2 3 WKO, MALE BCID2 RESULT(S) REPORTED - POSITIVE BLOOD CULTURE WITH STAPHYLOCOCCUS EPIDERMIDIS WITH MECA/C. ALL TESTING PERFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21907429 ↗
• MalfunctionFeb 26, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT FROM THE UNITED STATES OF FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT PF PLUS (PLASTIC) 100 BTLS - REF. 410853, LOT 0004102452. PATIENT # 1: BOTTLE ID: NOT PROVIDED GRAM STAIN: GRAM POSITIVE COCCI IN CLUSTERS SUBCULTURE: STAPHYLOCOCCUS AUREUS BCID RESULT: S. MARCESCENS. PATIENT # 2: BOTTLE ID: NOT PROVIDED GRAM STAIN: GRAM POSITIVE COCCI IN CHAINS SUBCULTURE: STREPTOCOCCUS PYOGENES BCID RESULT: S. MARCESCENS. 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 PHYSIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472433 ↗
• MalfunctionFeb 26, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT FROM THE UNITED STATES OF FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT PF PLUS (PLASTIC) 100 BTLS - REF.(B)(4), LOT 0004102452. PATIENT # 1: BOTTLE ID: NOT PROVIDED, GRAM STAIN: GRAM POSITIVE COCCI IN CLUSTERS, SUBCULTURE: STAPHYLOCOCCUS AUREUS, BCID RESULT: S. MARCESCENS. PATIENT # 2: BOTTLE ID: NOT PROVIDEDM GRAM STAIN: GRAM POSITIVE COCCI IN CHAINS, SUBCULTURE: STREPTOCOCCUS PYOGENES, BCID RESULT: S. MARCESCENS. 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 P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472430 ↗
• MalfunctionJan 14, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT FROM THE UNITED STATES OF FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT PF PLUS (PLASTIC) 100 BTLS - REF. 410853, LOT 0004102452. SUMMARY: - PATIENT 1: -- BCID2: STREPTOCOCCUS SPP, ENTEROBACTERALES, SERRATIA MARCESCENS -- BACT: STREPTOCOCCUS ORALIS. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE FALSE SERRATIA MARCESCENS RESULT. 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. THERE IS NO MALFUNCTION ASSOCIATED WITH THE BACT/ALERT SYSTEM/REA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21147001 ↗
• MalfunctionJan 14, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT FROM THE UNITED STATES OF FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT PF PLUS (PLASTIC) 100 BTLS - REF. 410853, LOT: 0004102452. SUMMARY: PATIENT (B)(6): BCID2: ENTEROBACTERALES, ESCHERICHIA COLI, SERRATIA MARCESCENS. BACT: ESCHERICHIA COLI. THE CUSTOMER CONFIRMED THAT WHILE THE SERRATIA MARCESCENS RESULT WAS REPORTED TO THE PHYSICIAN IT WAS ACCOMPANIED WITH A NOTE STATING DETECTED BY BCID2, UNABLE TO ISOLATE IN CULTURE. AT THE TIME OF THE GLOBAL ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21146981 ↗
• MalfunctionJan 8, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE. BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. DESCRIPTION OF THE ISSUE A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE OF S. MARCESCENS ON BCID2 PANEL WITH ONE (1) PATIENT SAMPLE WHEN TESTING BLOOD SAMPLE INOCULATED IN BACT/ALERT PF PLUS (PLASTIC) 100 BTLS - 410853 (LOT# 0004102452). RESULTS ARE SUMMARIZED BELOW: PATIENT # 1: FOUR-WEEK-OLD FEMALE. PATIENT SIGNS/SYMPTOMS: ATRIAL SEPTUM DEFECT. RESULTS REPORTED TO PHYSICIAN: ONLY S. AUREUS. PATIENT FINAL DIAGNOSIS: HEART ISSUES. BOTTLE ID: PRZCX867 GRAM STAIN RESULT: GRAM POSITIVE COCCI ONLY CULTURE RESULT: S. AUREUS BCID RESULT: DETECTED STAPH, S. AUREUS AND S. MARCESCENS. 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 INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101844 ↗
• MalfunctionJan 2, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT OF FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS FOR THE BCID2 PANEL FOR TWO DIFFERENT PATIENTS AFTER THE SAMPLES WERE INCUBATED IN A BACT/ALERT PF PLUS (PLASTIC) BOTTLE (REF (B)(4), LOT 0004102452). THE RESULT FOR THE BCID2 PANEL FOR PATIENT 1 WAS STAPHYLOCOCCUS EPIDERMIDIS AND SERRATIA MARCESCENS DETECTED. THE RESULT FOR THE BCID2 PANEL FOR PATIENT 2 WAS STAPHYLOCOCCUS SPECIES AND SERRATIA MARCESCENS DETECTED. THE GRAM STAIN RESULT FOR BOTH PATIENTS WAS GRAM POSITIVE COCCI IN CLUSTERS. CULTURES FOR BOTH PATIENTS GREW STAPHYLOCOCCUS ONLY WITH NO DEVELOPMENT OF S. MARCESCENS. THE CUSTOMER RECOVERED THE TRUE ORGANISMS (STAPHYLOCOCCUS EPIDERMIDIS AND STAPHYLOCOCCUS SPECIES) THAT WERE IN THE PATIENTS' SAMPLES, AS WELL AS DEAD DNA DETECTED FOR (SERRATIA MARCESCENS) ON THE BIOFIRE BCID2 PANEL. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060796 ↗
• MalfunctionJan 2, 2025Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT OF FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS FOR THE BCID2 PANEL FOR TWO DIFFERENT PATIENTS AFTER THE SAMPLES WERE INCUBATED IN A BACT/ALERT PF PLUS (PLASTIC) BOTTLE (REF 410853, LOT 0004102452). THE RESULT FOR THE BCID2 PANEL FOR PATIENT 1 WAS STAPHYLOCOCCUS EPIDERMIDIS AND SERRATIA MARCESCENS DETECTED. THE RESULT FOR THE BCID2 PANEL FOR PATIENT 2 WAS STAPHYLOCOCCUS SPECIES AND SERRATIA MARCESCENS DETECTED. THE GRAM STAIN RESULT FOR BOTH PATIENTS WAS GRAM POSITIVE COCCI IN CLUSTERS. CULTURES FOR BOTH PATIENTS GREW STAPHYLOCOCCUS ONLY WITH NO DEVELOPMENT OF S. MARCESCENS. THE CUSTOMER RECOVERED THE TRUE ORGANISMS (STAPHYLOCOCCUS EPIDERMIDIS AND STAPHYLOCOCCUS SPECIES) THAT WERE IN THE PATIENTS' SAMPLES, AS WELL AS DEAD DNA DETECTED FOR (SERRATIA MARCESCENS) ON THE BIOFIRE BCID2 PANEL. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060790 ↗
• MalfunctionDec 27, 2024Cross Reactivity; Cross Reactivity

  INTENDED USE BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. DESCRIPTION OF THE ISSUE A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE FOR S. MARCESCENS ON BCID2 PANEL WITH TWO (2) PATIENT SAMPLES WHEN TESTING BLOOD SAMPLE INOCULATED IN BACT/ALERT PF PLUS (PLASTIC) (B)(4) BTLS - 410853 (LOT# 0004102452, EXPIRATION DATE 03/03/2025). RESULTS ARE SUMMARIZED BELOW: PATIENT #1: - DATE OF BIRTH IS (B)(6) 1938. - PATIENT # 1 BLOOD CULTURE WAS COLLECTED ON (B)(6) 2024. CULTURES GREW ONLY STAPHYLOCOCCUS EPIDERMIDIS. - BCID2 RESULT REPORTED TO PHYSICIAN: PATIENT #1 HAD STAPHYLOCOCCUS EPI AND SERRATIA MARCESCENS REPORTED. - PATIENT'S FINAL DIAGNOSIS: PATIENT #1 WAS ¿SHORTNESS OF BREATH¿. PATIENT #2: - DATE OF BIRTH IS (B)(6) 1956. - PATIENT #2 BLOOD CULTURE WAS COLLECTED (B)(6) 2024. CULTURES GREW ONLY THE STAPHYLOCOCCUS EPIDERMIDIS. - BCID2 RESULT REPORTED TO PHYSICIAN: PATIENT #2 ALSO HAD STAPHYLOCOCCUS EPI AND SERRATIA MARCESCENS REPORTED. - PATIENT'S FINAL DIAGNOSIS: PATIENT #2 WAS COLITIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025677 ↗
• MalfunctionDec 27, 2024Cross Reactivity; Cross Reactivity

  INTENDED USE BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. DESCRIPTION OF THE ISSUE A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE FOR S. MARCESCENS ON BCID2 PANEL WITH TWO (2) PATIENT SAMPLES WHEN TESTING BLOOD SAMPLE INOCULATED IN BACT/ALERT PF PLUS (PLASTIC) 100 BTLS - 410853 (LOT# 0004102452, EXPIRATION DATE (B)(6) 2025). RESULTS ARE SUMMARIZED BELOW: PATIENT #1: DATE OF BIRTH IS (B)(6). PATIENT #1 BLOOD CULTURE WAS COLLECTED ON (B)(6) 2024. CULTURES GREW ONLY STAPHYLOCOCCUS EPIDERMIDIS. BCID2 RESULT REPORTED TO PHYSICIAN: PATIENT #1 HAD STAPHYLOCOCCUS EPI AND SERRATIA MARCESCENS REPORTED. PATIENT'S FINAL DIAGNOSIS: PATIENT #1 WAS ¿SHORTNESS OF BREATH¿. PATIENT #2: DATE OF BIRTH IS (B)(6). PATIENT #2 BLOOD CULTURE WAS COLLECTED (B)(6) 2024. CULTURES GREW ONLY THE STAPHYLOCOCCUS EPIDERMIDIS. BCID2 RESULT REPORTED TO PHYSICIAN: PATIENT #2 ALSO HAD STAPHYLOCOCCUS EPI AND SERRATIA MARCESCENS REPORTED. PATIENT'S FINAL DIAGNOSIS: PATIENT #2 WAS COLITIS. BOTH PATIENTS USED BACT/ALERT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025673 ↗
• MalfunctionDec 5, 2024Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT OF FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS WITH THE BCID2 PANEL FOR FOUR (4) PATIENTS AFTER THE SAMPLES WERE INCUBATED IN BACT/ALERT PF PLUS (PLASTIC) BOTTLES (REF (B)(4), LOT 0004102452). THE CUSTOMER REPORTED THAT THEY OBTAINED FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS WITH THE BCID2 PANEL WHILE SUBSEQUENT GRAM-STAIN AND SUBCULTURE RESULTS DID NOT CONFIRM THE PRESENCE OF S. MARCESCENS. ---PATIENT 1--- 67 YEAR OLD MALE CLINICAL SIGNS AND SYMPTOMS AT TIME OF TESTING: ACUTE RESPIRATORY FAILURE & PNEUMONIA PATIENT IMPACT: NONE BCID2 RESULT: STAPHYLOCOCCUS AUREUS AND SERRATIA MARCESCENS GRAM STAIN / SUBCULTURE: GRAM- POSITIVE COCCI ORGANISM RECOVERED: STAPHYLOCOCCUS AUREUS RESULT REPORTED: STAPHYLOCOCCUS AUREUS FINAL DIAGNOSIS: VENTILATOR ASSOCIATED PNEUMONIA & MRSA BACTEREMIA ---PATIENT 2--- 51 YEAR OLD MALE CLINICAL SIGNS AND SYMPT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854242 ↗
• MalfunctionDec 5, 2024Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT OF FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS WITH THE BCID2 PANEL FOR FOUR (4) PATIENTS AFTER THE SAMPLES WERE INCUBATED IN BACT/ALERT PF PLUS (PLASTIC) BOTTLES (REF 410853, LOT 0004102452). THE CUSTOMER REPORTED THAT THEY OBTAINED FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS WITH THE BCID2 PANEL WHILE SUBSEQUENT GRAM-STAIN AND SUBCULTURE RESULTS DID NOT CONFIRM THE PRESENCE OF S. MARCESCENS. ---PATIENT 1--- 67 YEAR OLD MALE CLINICAL SIGNS AND SYMPTOMS AT TIME OF TESTING: ACUTE RESPIRATORY FAILURE & PNEUMONIA PATIENT IMPACT: NONE BCID2 RESULT: STAPHYLOCOCCUS AUREUS AND SERRATIA MARCESCENS GRAM STAIN / SUBCULTURE: GRAM- POSITIVE COCCI ORGANISM RECOVERED: STAPHYLOCOCCUS AUREUS RESULT REPORTED: STAPHYLOCOCCUS AUREUS FINAL DIAGNOSIS: VENTILATOR ASSOCIATED PNEUMONIA & MRSA BACTEREMIA ---PATIENT 2--- 51 YEAR OLD MALE CLINICAL SIGNS AND SYMPT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854206 ↗
• MalfunctionDec 5, 2024Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT OF FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS WITH THE BCID2 PANEL FOR FOUR (4) PATIENTS AFTER THE SAMPLES WERE INCUBATED IN BACT/ALERT PF PLUS (PLASTIC) BOTTLES (REF 410853, LOT 0004102452). THE CUSTOMER REPORTED THAT THEY OBTAINED FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS WITH THE BCID2 PANEL WHILE SUBSEQUENT GRAM-STAIN AND SUBCULTURE RESULTS DID NOT CONFIRM THE PRESENCE OF S. MARCESCENS. ---PATIENT 1--- 67 YEAR OLD MALE CLINICAL SIGNS AND SYMPTOMS AT TIME OF TESTING: ACUTE RESPIRATORY FAILURE & PNEUMONIA PATIENT IMPACT: NONE BCID2 RESULT: STAPHYLOCOCCUS AUREUS AND SERRATIA MARCESCENS GRAM STAIN / SUBCULTURE: GRAM- POSITIVE COCCI ORGANISM RECOVERED: STAPHYLOCOCCUS AUREUS RESULT REPORTED: STAPHYLOCOCCUS AUREUS FINAL DIAGNOSIS: VENTILATOR ASSOCIATED PNEUMONIA & MRSA BACTEREMIA ---PATIENT 2--- 51 YEAR OLD MALE CLINICAL SIGNS AND SYMPT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854120 ↗
• MalfunctionDec 5, 2024Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT OF FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS WITH THE BCID2 PANEL FOR FOUR (4) PATIENTS AFTER THE SAMPLES WERE INCUBATED IN BACT/ALERT PF PLUS (PLASTIC) BOTTLES (REF 410853, LOT 0004102452). THE CUSTOMER REPORTED THAT THEY OBTAINED FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS WITH THE BCID2 PANEL WHILE SUBSEQUENT GRAM-STAIN AND SUBCULTURE RESULTS DID NOT CONFIRM THE PRESENCE OF S. MARCESCENS. PATIENT 1 67-YEAR-OLD MALE CLINICAL SIGNS AND SYMPTOMS AT TIME OF TESTING: ACUTE RESPIRATORY FAILURE & PNEUMONIA PATIENT IMPACT: NONE BCID2 RESULT: STAPHYLOCOCCUS AUREUS AND SERRATIA MARCESCENS GRAM STAIN / SUBCULTURE: GRAM- POSITIVE COCCI ORGANISM RECOVERED: STAPHYLOCOCCUS AUREUS RESULT REPORTED: STAPHYLOCOCCUS AUREUS FINAL DIAGNOSIS: VENTILATOR ASSOCIATED PNEUMONIA & MRSA BACTEREMIA. PATIENT 2 51-YEAR-OLD MALE CLINICAL SIGNS AND SYMPTOMS AT TIME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854016 ↗
• MalfunctionNov 19, 2024Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT FROM THE UNITED STATES OF FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT PF PLUS (PLASTIC) 100 BTLS - REF. 410853, LOT 0004102452. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL DUE TO SEPTIC SHOCK PRIOR TO BLOOD CULTURES RESULTING POSITIVE AND ULTIMATELY DIED. THE CUSTOMER NOTED THAT 2 BLOOD CULTURE BOTTLES WERE TESTED. THE FIRST BLOOD CULTURE BOTTLE WAS COLLECTED ON (B)(6) 2024 AND WAS NEGATIVE AT 5 DAYS OF INCUBATION. THE SECOND BOTTLE (PRZCMFCV) WAS COLLECTED ON 05 NOV AND RESULTED POSITIVE ON 06 NOV. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL BEFORE THE SECOND BLOOD CULTURE RESULTED POSITIVE DUE TO SEPTIC SHOCK. A GRAM STAIN WAS PERFORMED ON BOTTLE PRZCMFCV WITH GPC IN CLUSTERS IDENTIFIED. THE SAMPLE WAS THEN RAN ON BCID 2 WITH THE FOLLOWING RESULTS: S. AUREUS DETECTED, MECA/C AND MREJ NOT DETECTED; S. MARCESCENS AND STREP. SP.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 20723643 ↗
• MalfunctionNov 18, 2024Cross 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 SAMPLE A USING BACT/ALERT PF PLUS (PLASTIC) REF (B)(4), LOT 0004102452 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 RESULTS OF SERRATIA MARCESCENS. THE CUSTOMER MENTIONED THAT ADDITIONAL TESTING WAS PERFORMED AND THE FOLLOWING RESULTS WERE OBTAINED: FILMARRAY RESULTS = SERRATIA MARCESCENS AND STREPTOCOCCUS PNEUMONIAE. GRAM STAIN RESULTS = GPC IN CHAINS. CULTURE RESULTS = STREPTOCOCCUS PNEUMONIAE. THE CUSTOMER STATES THAT STREPTOCOCCUS PNEUMONIAE WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER SAID THAT THEY HAD TESTED SAMPLE B USING THE SAME LOT OF BACT/ALERT PF PLUS (PLASTIC) IN CONJUNCTION WITH THEIR BACT/ALERT SYSTEM AND TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20704312 ↗
• MalfunctionNov 18, 2024Cross 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 SAMPLE A USING BACT/ALERT PF PLUS (PLASTIC) REF (B)(4) LOT 0004102452 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 RESULTS OF SERRATIA MARCESCENS. THE CUSTOMER MENTIONED THAT ADDITIONAL TESTING WAS PERFORMED AND THE FOLLOWING RESULTS WERE OBTAINED: FILMARRAY RESULTS = SERRATIA MARCESCENS AND STREPTOCOCCUS PNEUMONIAE GRAM STAIN RESULTS = GPC IN CHAINS. CULTURE RESULTS = STREPTOCOCCUS PNEUMONIAE. THE CUSTOMER STATES THAT STREPTOCOCCUS PNEUMONIAE WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER SAID THAT THEY HAD TESTED SAMPLE B USING THE SAME LOT OF BACT/ALERT PF PLUS (PLASTIC) IN CONJUNCTION WITH THEIR BACT/ALERT SYSTEM AND THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20704291 ↗
• MalfunctionNov 14, 2024Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT OF FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS FOR THE BCID2 PANEL AFTER THE SAMPLES WERE INCUBATED IN A BACT/ALERT PF PLUS (PLASTIC) BOTTLE (REF 410853, LOT 0004102452). THE ISSUE WAS REPORTED FOR TWO DIFFERENT PATIENTS. THE RESULT FOR THE BCID2 PANEL WAS STREPTOCOCCUS PNEUMONIAE, STREPTOCOCCUS AGALACTIAE (GBS), KLEBSIELLA PNEUMONIAE, AND SERRATIA MARCESCENS DETECTED. IN THE CULTURES THERE WAS DEVELOPMENT OF KLEBSIELLA PNEUMONIAE, STREPTOCOCCUS PNEUMONIAE, STREPTOCOCCUS AGALACTIAE (GBS), BUT THERE WAS NO DEVELOPMENT OF S. MARCESCENS. THE CUSTOMER RECOVERED THE TRUE ORGANISMS (STREPTOCOCCUS PNEUMONIAE, STREPTOCOCCUS AGALACTIAE (GBS), KLEBSIELLA PNEUMONIAE) THAT WERE IN THE PATIENTS' SAMPLES, AS WELL AS DEAD DNA DETECTED FOR (SERRATIA MARCESCENS) ON THE BIOFIRE BCID2 PANEL. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683997 ↗
• MalfunctionNov 14, 2024Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT OF FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS FOR THE BCID2 PANEL AFTER THE SAMPLES WERE INCUBATED IN A BACT/ALERT PF PLUS (PLASTIC) BOTTLE (REF 410853, LOT 0004102452). THE ISSUE WAS REPORTED FOR TWO DIFFERENT PATIENTS. THE RESULT FOR THE BCID2 PANEL WAS STREPTOCOCCUS PNEUMONIAE, STREPTOCOCCUS AGALACTIAE (GBS), KLEBSIELLA PNEUMONIAE, AND SERRATIA MARCESCENS DETECTED. IN THE CULTURES THERE WAS DEVELOPMENT OF KLEBSIELLA PNEUMONIAE, STREPTOCOCCUS PNEUMONIAE, STREPTOCOCCUS AGALACTIAE (GBS), BUT THERE WAS NO DEVELOPMENT OF S. MARCESCENS. THE CUSTOMER RECOVERED THE TRUE ORGANISMS (STREPTOCOCCUS PNEUMONIAE, STREPTOCOCCUS AGALACTIAE (GBS), KLEBSIELLA PNEUMONIAE) THAT WERE IN THE PATIENTS' SAMPLES, AS WELL AS DEAD DNA DETECTED FOR (SERRATIA MARCESCENS) ON THE BIOFIRE BCID2 PANEL. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683988 ↗
• MalfunctionNov 14, 2024Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT OF A FALSE POSITIVE RESULT FOR SERRATIA MARCESCENS FOR THE BCID2 PANEL AFTER THE SAMPLE WAS INCUBATED IN A BACT/ALERT PF PLUS (PLASTIC) BOTTLE (REF (B)(4), LOT 0004102452). THE RESULT FOR THE BCID2 PANEL WAS KLEBSIELLA PNEUMONIAE, STREPTOCOCCUS PNEUMONIAE, STREPTOCOCCUS AGALACTIAE (GBS), AND SERRATIA MARCESCENS DETECTED. IN THE CULTURES THERE WAS DEVELOPMENT OF KLEBSIELLA PNEUMONIAE, STREPTOCOCCUS PNEUMONIAE, STREPTOCOCCUS AGALACTIAE (GBS), BUT THERE WAS NO DEVELOPMENT OF S. MARCESCENS. THE CUSTOMER RECOVERED THE TRUE ORGANISMS (KLEBSIELLA PNEUMONIAE, STREPTOCOCCUS PNEUMONIAE, STREPTOCOCCUS AGALACTIAE) THAT WERE IN THE PATIENT'S SAMPLE, AS WELL AS DEAD DNA DETECTED FOR (SERRATIA MARCESCENS) 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 INTEND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683833 ↗
• MalfunctionNov 13, 2024Cross Reactivity; Cross Reactivity

  13 NOV 2024: ISSUE DESCRIPTION HAS BEEN CORRECTED TO DOCUMENT THE CORRECT LOT NUMBER AND 4 IMPACTED PATIENTS. SEE BELOW FOR UPDATES. INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT FROM THE UNITED STATES OF FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT PF PLUS (PLASTIC) 100 BTLS - REF. 410853, LOT 0004102452. SUMMARY: PATIENT 1: BCID2: S. MARCESCENS BACT: NEGATIVE. PATIENT 2: BCID2: S. MARCESCENS BACT: NEGATIVE. PATIENT 3: BCID2: S. MARCESCENS BACT: NEGATIVE. PATIENT 4: BCID2: S. MARCESCENS BACT: NEGATIVE. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678229 ↗
• MalfunctionNov 4, 2024Cross Reactivity; Cross Reactivity

  (B)(6) 2024: ISSUE DESCRIPTION HAS BEEN CORRECTED TO DOCUMENT THE CORRECT LOT NUMBER AND 4 IMPACTED PATIENTS. SEE BELOW FOR UPDATES. INTENDED USE: BACT/ALERT® PF PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA AND YEAST) FROM BLOOD. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT FROM THE UNITED STATES OF FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT PF PLUS (PLASTIC) 100 BTLS - REF. (B)(4), LOT 0004102452. SUMMARY: - PATIENT 1: -- BCID2: S. MARCESCENS. -- BACT: NEGATIVE. - PATIENT 2: -- BCID2: S. MARCESCENS. -- BACT: NEGATIVE. - PATIENT 3: -- BCID2: S. MARCESCENS. -- BACT: NEGATIVE. - PATIENT 4: -- BCID2: S. MARCESCENS. -- BACT: NEGATIVE. 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 POSITI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605802 ↗