BACT/ALERT® SARecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 03573026595739), received between Aug 17, 2017 and Feb 13, 2023 — classified as 9 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Contamination” (12 reports).

1 other recall cover devices cleared under the same FDA submission (K020931); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2023False Positive Result; False Positive Result

  AS PART OF A STUDY CONDUCTED ON POSITIVE RATE IN HIS LABORATORY, A CUSTOMER IN UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT SA (PLASTIC) -(B)(4). THE CUSTOMER NOTED THAT BASED ON THE FALSE POSITIVE RESULTS PATIENTS WERE KEPT LONGER AND FLOWN OUT TO OTHER HOSPITALS. THE CUSTOMER ALSO CONFIRMED THAT ANTIBIOTICS WERE PRESCRIBED BASED ON THE FALSE POSITIVE RESULTS. THE CUSTOMER MENTIONS THAT THESE FALSE RESULTS HAS LED TO PATIENTS BEING KEPT LONGER OR FLOWN OUT. THE CUSTOMER ALSO CONFIRMED THAT THE PHYSICIAN HAD PRESCRIBED ANTIBIOTICS TO THE PATIENTS BASED ON THE FALSE POSITIVE RESULTS. AT THE TIME OF THE ASSESSMENT, THE CUSTOMER HAS NOT CONFIRMED IF THE FALSE POSITIVE RESULT IS A CLINICAL FALSE POSITIVE OR IF THEY ARE RELATED TO PROBABLE CONTAMINANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16365543 ↗
• MalfunctionDec 2, 2021False Positive Result; False Positive Result

  INTENDED USE: BACT/ALERT® SA CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF AEROBIC MICROORGANISMS (BACTERIA AND FUNGI) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION: A CUSTOMER IN IRELAND NOTIFIED BIOMÉRIEUX OF A POTENTIAL CONTAMINATION ISSUE. THE CUSTOMER REPORTED OBTAINING POSITIVE GROWTH RESULTS FOR AN "UNUSUAL" ORGANISM IN A BLOOD CULTURE SAMPLE IN ASSOCIATION WITH THE BACT/ALERT® SA (REF 259789, LOT 0001057294). THE CUSTOMER REPORTED THAT THE RECOVERED ORGANISM WAS IDENTIFIED AS PAENIBACILLUS PABULLI. GLOBAL CUSTOMER SERVICE (GCS) CONFIRMED THAT THE BOTTLE WORKED AS INTENDED AND WAS ABLE TO DETECT THE GROWTH OF P. PABULLI. THIS BACTERIA CAN PRODUCE SPORES THAT ARE TOUGH, HIGH-RESISTANT CELLS TO ENVIRONMENTALLY HARSH CONDITIONS. IT IS PRIMARILY FOUND IN THE ENVIRONMENT: E.G. SOIL AND WATER. PAENIBACILLUS IS A BACILLUS SPECIES THAT PRODUCES SPORES WHICH MAKES THEM COMMON ENVIRONMENTAL CONTAMINANTS IN CULTURES AND CAN BE FOUND IN POST SAMPLE INOCULATION. CUSTOMERS ARE INSTRUCTED WITHIN THE INFORMATION FOR USE [IFU] TO REDUCE SKIN/BOTTLE CONTAMINATION THROUGH DISINFECTING METHODS P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916974 ↗
• MalfunctionDec 2, 2021False Positive Result; False Positive Result

  INTENDED USE: BACT/ALERT® SA CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF AEROBIC MICROORGANISMS (BACTERIA AND FUNGI) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A POTENTIAL CONTAMINATION ISSUE. THE CUSTOMER REPORTED OBTAINING POSITIVE GROWTH RESULTS FOR AN "UNUSUAL" ORGANISM IN A BLOOD CULTURE SAMPLE IN ASSOCIATION WITH THE BACT/ALERT® SA (REF 259789, LOT 0001057016). THE CUSTOMER REPORTED THAT THE RECOVERED ORGANISM WAS IDENTIFIED AS PAENIBACILLUS PABULLI. GLOBAL CUSTOMER SERVICE (GCS) CONFIRMED THAT THE BOTTLE WORKED AS INTENDED AND WAS ABLE TO DETECT THE GROWTH OF P. PABULLI. THIS BACTERIA CAN PRODUCE SPORES THAT ARE TOUGH, HIGH-RESISTANT CELLS TO ENVIRONMENTALLY HARSH CONDITIONS. IT IS PRIMARILY FOUND IN THE ENVIRONMENT: E.G. SOIL AND WATER. PAENIBACILLUS IS A BACILLUS SPECIES THAT PRODUCES SPORES WHICH MAKES THEM COMMON ENVIRONMENTAL CONTAMINANTS IN CULTURES AND CAN BE FOUND IN POST SAMPLE INOCULATION. CUSTOMERS ARE INSTRUCTED WITHIN THE INFORMATION FOR USE [IFU] TO REDUCE SKIN/BOTTLE CONTAMINATION THROUGH DISINFECTING METHODS PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916846 ↗
• MalfunctionJul 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING BIOMÉRIEUX FSE (FIELD SERVICE ENGINEER) INTERVENTION AT A UNITED STATES CUSTOMER SITE, THE FSE IDENTIFIED DRIED BLOOD INSIDE THE CUSTOMER'S INSTRUMENT ON ALL DRIP TRAYS WITHIN THE INSTRUMENT. THE FSE STATED THE CUSTOMER DOES NOT PAD TUBE CARRIERS WHEN USING THE TUBE STATION FOR TRANSPORTING BACT/ALERT BLOOD CULTURE BOTTLES. THE FSE ASKED TO THE CUSTOMER IF THEY HAVE EVER IDENTIFIED A BROKEN BOTTLE, AND THE CUSTOMER STATED THEY HAVE NOT. IN THIS CASE, THERE WAS A POTENTIAL SAFETY HAZARD FROM BLOOD SPILL(S). BIOMÉRIEUX INSTRUCTED THE CUSTOMER TO CLEAN THE DRIED BLOOD WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). 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, NOR THE HEALTH OF THE USER(S). BIOMERIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159718 ↗
• MalfunctionDec 9, 2020False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF REAGENT (B)(6) RESULTS FOR (B)(6) ATCC® 6538¿ WHILE PERFORMING QUALITY CONTROL (QC) TESTING WITH BACT/ALERT® SA BOTTLES (REF. 259789, LOT 0001055384). LOT 0001055384 WAS INOCULATED WITH (B)(6) ATCC® 6538¿ AND (B)(6) AUREUS ATCC® 25923¿. THE CUSTOMER STATED (B)(6) RESULTS WERE OBTAINED FOR THE BOTTLES INOCULATED WITH (B)(6) ATCC® 25923¿; HOWEVER, BOTTLES WITH (B)(6) ATCC® 6538¿ OBTAINED (B)(6) RESULTS. ADDITIONALLY, THE CUSTOMER ALSO TESTED (B)(6) ATCC® 6538¿ USING THE BACT/ALERT FA PLUS CULTURE BOTTLE AND OBTAINED (B)(6) RESULTS. BIOMERIEUX CUSTOMER SERVICE REQUESTED THE CUSTOMERS BACK UP DATA AS WELL AS DETAILS REGARDING THE CUSTOMER¿S SAMPLE PREPARATION AND HANDLING TECHNIQUES. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 10980239 ↗
• MalfunctionOct 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF REAGENT FALSE NEGATIVE RESULTS FOR STAPHYLOCOCCUS AUREUS ATCC® 6538¿ AND ATCC® 25923¿ WHILE PERFORMING QUALITY CONTROL (QC) TESTING WITH BACT/ALERT® SA BOTTLES (REF: 259789, LOT: 0001055230). THE FALSE NEGATIVE RESULTS OCCURRED DURING QC TESTING AND THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT FALSE NEGATIVE RESULTS HAVE BEEN OBTAINED FOR ANY PATIENT SAMPLES. THE CUSTOMER STATED THAT QC TESTING WITH STAPHYLOCOCCUS AUREUS ATCC® 6538¿ DID NOT OBTAIN A POSITIVE RESULT WITH THE BACT/ALERT SA BOTTLES WHILE PARALLEL TESTING ON THE BD BACTEC SYSTEM OBTAINED POSITIVE RESULTS. THE STRAIN REPORTEDLY GREW WELL ON CULTURE MEDIA PRIOR TO INOCULATION, BUT AFTER INOCULATION. THE CUSTOMER ALSO PERFORMED TESTING WITH STAPHYLOCOCCUS AUREUS ATCC® 25923¿ WITH THE BACT/ALERT SA BOTTLES AND DID NOT OBTAIN POSITIVE RESULTS. QC TESTING WITH BACILLUS SUBTILIS AND ASPERGILLUS ORGANISMS OBTAINED POSITIVE RESULTS AS EXPECTED. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10678440 ↗
• MalfunctionOct 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF REAGENT FALSE NEGATIVE RESULTS FOR STAPHYLOCOCCUS AUREUS ATCC® 6538¿ AND ATCC® 25923¿ WHILE PERFORMING QUALITY CONTROL (QC) TESTING WITH BACT/ALERT® SA BOTTLES (REF 259789, LOT 0001054432). THE FALSE NEGATIVE RESULTS OCCURRED DURING QC TESTING AND THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT FALSE NEGATIVE RESULTS HAVE BEEN OBTAINED FOR ANY PATIENT SAMPLES. THE CUSTOMER STATED THAT QC TESTING WITH STAPHYLOCOCCUS AUREUS ATCC® 6538¿ DID NOT OBTAIN A POSITIVE RESULT WITH THE BACT/ALERT SA BOTTLES WHILE PARALLEL TESTING ON THE BD BACTEC SYSTEM OBTAINED POSITIVE RESULTS. THE STRAIN REPORTEDLY GREW WELL ON CULTURE MEDIA PRIOR TO INOCULATION, BUT AFTER INOCULATION THE BOTTLES DID NOT FLAG POSITIVE FOR GROWTH. THE CUSTOMER ALSO STATED THAT THE BOTTLES DID NOT APPEAR TO SHOW SIGNS OF TURBIDITY AND/OR GROWTH. THE CUSTOMER ALSO PERFORMED TESTING WITH STAPHYLOCOCCUS AUREUS ATCC® 25923¿ WITH THE BACT/ALERT SA BOTTLES AND DID NOT OBTAIN POSITIVE RESULTS. QC TESTING WITH BACILLUS SUBTILIS AND ASPERGILLUS ORGANISMS OBTAINED POSITIVE RESULTS AS EXPECTED. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10678415 ↗
• InjuryAug 16, 2019Contamination; Contamination

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF SUSPECTED CONTAMINATION RESULTS IN ASSOCIATION WITH BACT/ALERT® CULTURE BOTTLES. THE CUSTOMER REPORTED OBTAINING AN UNUSUALLY HIGH NUMBER OF (B)(6) BOTTLE RESULTS FOR MULTIPLE PATIENTS BETWEEN (B)(6) 2019. THE BOTTLES GREW STAPHYLOCOCCUS AUREUS. SUSCEPTIBILITY TESTING (METHOD NOT SPECIFIED) DETERMINED THE ORGANISMS TO BE METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE CULTURE BOTTLE SAMPLES HAD BEEN COLLECTED FROM DIFFERENT LOCATIONS IN THE FACILITY AND BY DIFFERENT COLLECTORS. ADDITIONALLY, SOME OF THE CONCERNED BOTTLES WERE FROM AN OFF-SITE FACILITY. THE BOTTLES FLAGGED (B)(6) AT DAY 3 TO DAY 4 OF THEIR INCUBATION PERIOD. THE TIMES TO DETECTION ARE CONSISTENT WITH THE ORGANISM ENTERING THE BOTTLE AT TIME OF SAMPLE INOCULATION. THERE WAS NO MALFUNCTION WITH THE BACT/ALERT BOTTLES AND 3D INSTRUMENT AS THE BOTTLES AND INSTRUMENT OPERATED AS EXPECTED WHEN AN ORGANISM IS DETECTED ON THE INSTRUMENT. THE CUSTOMER REPORTED THE FOLLOWING BOTTLE TYPES AND LOTS WERE CONCERNED: BACT/ALERT SA: LOT # 1053278, EXP. 2020-03-07, LOT # 1053290, EXP. 2020-03-12, LOT # 1052766, EXP. 2020-01-01, LOT # 1053418, EXP. 2020-04-01, LOT # 105

  Patient problems: Misdiagnosis

  MAUDE report 8903728 ↗
• InjuryAug 16, 2019Contamination; Contamination

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF SUSPECTED CONTAMINATION RESULTS IN ASSOCIATION WITH BACT/ALERT® CULTURE BOTTLES. THE CUSTOMER REPORTED OBTAINING AN UNUSUALLY HIGH NUMBER OF (B)(6) BOTTLE RESULTS FOR MULTIPLE PATIENTS BETWEEN (B)(6) 2019. THE BOTTLES GREW STAPHYLOCOCCUS AUREUS. SUSCEPTIBILITY TESTING (METHOD NOT SPECIFIED) DETERMINED THE ORGANISMS TO BE METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE CULTURE BOTTLE SAMPLES HAD BEEN COLLECTED FROM DIFFERENT LOCATIONS IN THE FACILITY AND BY DIFFERENT COLLECTORS. ADDITIONALLY, SOME OF THE CONCERNED BOTTLES WERE FROM AN OFF-SITE FACILITY. THE BOTTLES FLAGGED (B)(6) AT DAY 3 TO DAY 4 OF THEIR INCUBATION PERIOD. THE TIMES TO DETECTION ARE CONSISTENT WITH THE ORGANISM ENTERING THE BOTTLE AT TIME OF SAMPLE INOCULATION. THERE WAS NO MALFUNCTION WITH THE BACT/ALERT BOTTLES AND 3D INSTRUMENT AS THE BOTTLES AND INSTRUMENT OPERATED AS EXPECTED WHEN AN ORGANISM IS DETECTED ON THE INSTRUMENT. THE CUSTOMER REPORTED THE FOLLOWING BOTTLE TYPES AND LOTS WERE CONCERNED: BACT/ALERT SA: LOT # 1053278, EXP. 2020-03-07, LOT # 1053290, EXP. 2020-03-12, LOT # 1052766, EXP. 2020-01-01, LOT # 1053418, EXP. 2020-04-01, LOT # 105

  Patient problems: Misdiagnosis

  MAUDE report 8903715 ↗
• InjuryAug 16, 2019Contamination; Contamination

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF SUSPECTED CONTAMINATION RESULTS IN ASSOCIATION WITH BACT/ALERT® CULTURE BOTTLES. THE CUSTOMER REPORTED OBTAINING AN UNUSUALLY HIGH NUMBER OF (B)(6) BOTTLE RESULTS FOR MULTIPLE PATIENTS BETWEEN (B)(6) 2019. THE BOTTLES GREW (B)(6). SUSCEPTIBILITY TESTING (METHOD NOT SPECIFIED) DETERMINED THE ORGANISMS TO BE (B)(6). THE CULTURE BOTTLE SAMPLES HAD BEEN COLLECTED FROM DIFFERENT LOCATIONS IN THE FACILITY AND BY DIFFERENT COLLECTORS. ADDITIONALLY, SOME OF THE CONCERNED BOTTLES WERE FROM AN OFF-SITE FACILITY. THE BOTTLES FLAGGED (B)(6) AT DAY 3 TO DAY 4 OF THEIR INCUBATION PERIOD. THE TIMES TO DETECTION ARE CONSISTENT WITH THE ORGANISM ENTERING THE BOTTLE AT TIME OF SAMPLE INOCULATION. THERE WAS NO MALFUNCTION WITH THE BACT/ALERT BOTTLES AND 3D INSTRUMENT AS THE BOTTLES AND INSTRUMENT OPERATED AS EXPECTED WHEN AN ORGANISM IS DETECTED ON THE INSTRUMENT. THE CUSTOMER REPORTED THE FOLLOWING BOTTLE TYPES AND LOTS WERE CONCERNED: BACT/ALERT SA: LOT # 1053278, EXP. 2020-03-07; LOT # 1053290, EXP. 2020-03-12; LOT # 1052766, EXP. 2020-01-01; LOT # 1053418, EXP. 2020-04-01; LOT # 1052142, EXP. 2019-10-03; LOT # 1052254, EXP. 2019-10-17. BACT

  Patient problems: Misdiagnosis

  MAUDE report 8903707 ↗
• InjuryAug 16, 2019Contamination; Contamination

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF SUSPECTED CONTAMINATION RESULTS IN ASSOCIATION WITH BACT/ALERT® CULTURE BOTTLES. THE CUSTOMER REPORTED OBTAINING AN UNUSUALLY HIGH NUMBER OF (B)(6) BOTTLE RESULTS FOR MULTIPLE PATIENTS BETWEEN (B)(6) 2019. THE BOTTLES GREW STAPHYLOCOCCUS AUREUS. SUSCEPTIBILITY TESTING (METHOD NOT SPECIFIED) DETERMINED THE ORGANISMS TO BE METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE CULTURE BOTTLE SAMPLES HAD BEEN COLLECTED FROM DIFFERENT LOCATIONS IN THE FACILITY AND BY DIFFERENT COLLECTORS. ADDITIONALLY, SOME OF THE CONCERNED BOTTLES WERE FROM AN OFF-SITE FACILITY. THE BOTTLES FLAGGED (B)(6) AT DAY 3 TO DAY 4 OF THEIR INCUBATION PERIOD. THE TIMES TO DETECTION ARE CONSISTENT WITH THE ORGANISM ENTERING THE BOTTLE AT TIME OF SAMPLE INOCULATION. THERE WAS NO MALFUNCTION WITH THE BACT/ALERT BOTTLES AND 3D INSTRUMENT AS THE BOTTLES AND INSTRUMENT OPERATED AS EXPECTED WHEN AN ORGANISM IS DETECTED ON THE INSTRUMENT. THE CUSTOMER REPORTED THE FOLLOWING BOTTLE TYPES AND LOTS WERE CONCERNED: BACT/ALERT SA: LOT # 1053278, EXP. 2020-03-07, LOT # 1053290, EXP. 2020-03-12, LOT # 1052766, EXP. 2020-01-01, LOT # 1053418, EXP. 2020-04-01, LOT # 105

  Patient problems: Misdiagnosis

  MAUDE report 8903706 ↗
• InjuryAug 16, 2019Contamination; Contamination

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF SUSPECTED CONTAMINATION RESULTS IN ASSOCIATION WITH BACT/ALERT® CULTURE BOTTLES. THE CUSTOMER REPORTED OBTAINING AN UNUSUALLY HIGH NUMBER OF (B)(6) BOTTLE RESULTS FOR MULTIPLE PATIENTS BETWEEN (B)(6) 2019. THE BOTTLES GREW STAPHYLOCOCCUS AUREUS. SUSCEPTIBILITY TESTING (METHOD NOT SPECIFIED) DETERMINED THE ORGANISMS TO BE METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE CULTURE BOTTLE SAMPLES HAD BEEN COLLECTED FROM DIFFERENT LOCATIONS IN THE FACILITY AND BY DIFFERENT COLLECTORS. ADDITIONALLY, SOME OF THE CONCERNED BOTTLES WERE FROM AN OFF-SITE FACILITY. THE BOTTLES FLAGGED (B)(6) AT DAY 3 TO DAY 4 OF THEIR INCUBATION PERIOD. THE TIMES TO DETECTION ARE CONSISTENT WITH THE ORGANISM ENTERING THE BOTTLE AT TIME OF SAMPLE INOCULATION. THERE WAS NO MALFUNCTION WITH THE BACT/ALERT BOTTLES AND 3D INSTRUMENT AS THE BOTTLES AND INSTRUMENT OPERATED AS EXPECTED WHEN AN ORGANISM IS DETECTED ON THE INSTRUMENT. THE CUSTOMER REPORTED THE FOLLOWING BOTTLE TYPES AND LOTS WERE CONCERNED: BACT/ALERT SA: LOT # 1053278, EXP. 2020-03-07, LOT # 1053290, EXP. 2020-03-12, LOT # 1052766, EXP. 2020-01-01, LOT # 1053418, EXP. 2020-04-01, LOT # 105

  Patient problems: Misdiagnosis

  MAUDE report 8903696 ↗
• InjuryAug 16, 2019Contamination; Contamination

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF SUSPECTED CONTAMINATION RESULTS IN ASSOCIATION WITH BACT/ALERT® CULTURE BOTTLES. THE CUSTOMER REPORTED OBTAINING AN UNUSUALLY HIGH NUMBER OF (B)(6) BOTTLE RESULTS FOR MULTIPLE PATIENTS BETWEEN (B)(6) 2019. THE BOTTLES GREW STAPHYLOCOCCUS AUREUS. SUSCEPTIBILITY TESTING (METHOD NOT SPECIFIED) DETERMINED THE ORGANISMS TO BE METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE CULTURE BOTTLE SAMPLES HAD BEEN COLLECTED FROM DIFFERENT LOCATIONS IN THE FACILITY AND BY DIFFERENT COLLECTORS. ADDITIONALLY, SOME OF THE CONCERNED BOTTLES WERE FROM AN OFF-SITE FACILITY. THE BOTTLES FLAGGED (B)(6) AT DAY 3 TO DAY 4 OF THEIR INCUBATION PERIOD. THE TIMES TO DETECTION ARE CONSISTENT WITH THE ORGANISM ENTERING THE BOTTLE AT TIME OF SAMPLE INOCULATION. THERE WAS NO MALFUNCTION WITH THE BACT/ALERT BOTTLES AND 3D INSTRUMENT AS THE BOTTLES AND INSTRUMENT OPERATED AS EXPECTED WHEN AN ORGANISM IS DETECTED ON THE INSTRUMENT. THE CUSTOMER REPORTED THE FOLLOWING BOTTLE TYPES AND LOTS WERE CONCERNED: BACT/ALERT SA: LOT # 1053278, EXP. 2020-03-07, LOT # 1053290, EXP. 2020-03-12, LOT # 1052766, EXP. 2020-01-01, LOT # 1053418, EXP. 2020-04-01, LOT # 105

  Patient problems: Misdiagnosis

  MAUDE report 8903673 ↗
• MalfunctionAug 8, 2019Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF RECOVERING BACILLUS SPECIES WHEN TESTING WITH BACT/ALERT® SA BOTTLES (LOTS 1052576, 1053278 AND 1053002), BACT/ALERT SN BOTTLES (LOTS 1053350, 1052950 AND 1053162) AND BACT/ALERT FA BOTTLES (LOT 1053482). THE CUSTOMER REPORTED THAT THE SUSPECTED CONTAMINATION OF BACILLUS WAS OBTAINED FOR MULTIPLE PATIENTS. THE CUSTOMER STATED THERE WAS NO DELAY IN REPORTING RESULTS. THE CUSTOMER REPORTED THE PHYSICIAN SUSPECTED THE RESULTS WERE CONTAMINATION. NO PATIENT WAS TREATED FOR BACILLUS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8876616 ↗
• MalfunctionAug 8, 2019Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF RECOVERING BACILLUS SPECIES WHEN TESTING WITH BACT/ALERT® SA BOTTLES (LOTS 1052576, 1053278 AND 1053002), BACT/ALERT SN BOTTLES (LOTS 1053350, 1052950 AND 1053162) AND BACT/ALERT FA BOTTLES (LOT 1053482). THE CUSTOMER REPORTED THAT THE SUSPECTED CONTAMINATION OF BACILLUS WAS OBTAINED FOR MULTIPLE PATIENTS. THE CUSTOMER STATED THERE WAS NO DELAY IN REPORTING RESULTS. THE CUSTOMER REPORTED THE PHYSICIAN SUSPECTED THE RESULTS WERE CONTAMINATION. NO PATIENT WAS TREATED FOR BACILLUS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8876614 ↗
• MalfunctionAug 6, 2019Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF RECOVERING BACILLUS SPECIES WHEN TESTING WITH BACT/ALERT® SA BOTTLES (LOTS 1052576, 1053278 AND 1053002), BACT/ALERT SN BOTTLES (LOTS 1053350, 1052950 AND 1053162) AND BACT/ALERT FA BOTTLES (LOT 1053482). THE CUSTOMER REPORTED THAT THE SUSPECTED CONTAMINATION OF BACILLUS WAS OBTAINED FOR MULTIPLE PATIENTS. THE CUSTOMER STATED THERE WAS NO DELAY IN REPORTING RESULTS. THE CUSTOMER REPORTED THE PHYSICIAN SUSPECTED THE RESULTS WERE CONTAMINATION. NO PATIENT WAS TREATED FOR BACILLUS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8864483 ↗
• MalfunctionAug 6, 2019Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF RECOVERING BACILLUS SPECIES WHEN TESTING WITH BACT/ALERT® SA BOTTLES (LOTS 1052576, 1053278 AND 1053002), BACT/ALERT SN BOTTLES (LOTS 1053350, 1052950 AND 1053162) AND BACT/ALERT FA BOTTLES (LOT 1053482). THE CUSTOMER REPORTED THAT THE SUSPECTED CONTAMINATION OF BACILLUS WAS OBTAINED FOR MULTIPLE PATIENTS. THE CUSTOMER STATED THERE WAS NO DELAY IN REPORTING RESULTS. THE CUSTOMER REPORTED THE PHYSICIAN SUSPECTED THE RESULTS WERE CONTAMINATION. NO PATIENT WAS TREATED FOR BACILLUS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8864482 ↗
• MalfunctionAug 6, 2019Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF RECOVERING BACILLUS SPECIES WHEN TESTING WITH BACT/ALERT® SA BOTTLES (LOTS 1052576, 1053278 AND 1053002), BACT/ALERT SN BOTTLES (LOTS 1053350, 1052950 AND 1053162) AND BACT/ALERT FA BOTTLES (LOT 1053482). THE CUSTOMER REPORTED THAT THE SUSPECTED CONTAMINATION OF BACILLUS WAS OBTAINED FOR MULTIPLE PATIENTS. THE CUSTOMER STATED THERE WAS NO DELAY IN REPORTING RESULTS. THE CUSTOMER REPORTED THE PHYSICIAN SUSPECTED THE RESULTS WERE CONTAMINATION. NO PATIENT WAS TREATED FOR BACILLUS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8864481 ↗
• InjuryApr 17, 2019False Negative Result; False Negative Result

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT WHEN TESTING WITH THE BACT/ALERT® SA BOTTLE (REF 259789) AND THE BACT/ALERT® 3D INSTRUMENT. THE CUSTOMER REPORTED UNLOADING THE BACT/ALERT SA BOTTLE, RESULTING AS A FINAL NEGATIVE, AFTER FIVE DAYS OF INCUBATION. THE TECHNICIAN NOTED THAT THE BOTTLE INDICATOR SENSOR ON THE BOTTOM OF THE BOTTLE WAS YELLOW. THE TECHNICIAN FOLLOWED THEIR PROTOCOL FOR THIS FINDING AND PERFORMED A SUBCULTURE AND GRAM STAIN. THE ORGANISM ISOLATED FROM THIS SUBCULTURE WAS KLEBSIELLA PNEUMONIAE. GRAM STAIN RESULTS REVEALED GRAM NEGATIVE RODS. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS NOT ON ANTIBIOTICS AT THE TIME OF SPECIMEN COLLECTION. THE CUSTOMER REPORTED CONFIRMING THE IDENTIFICATION WITH THE VITEK® 2 AND BIOFIRE® FILMARRAY INSTRUMENT. ACCORDING TO THE CUSTOMER, THE BOTTLE WAS COLLECTED ON (B)(6) 2019 AT 0230 AND LOADED INTO CELL # 1C11 ON (B)(6) 2019 AT 0337. THE BOTTLE WAS DETERMINED NEGATIVE BY THE INSTRUMENT ON (B)(6) 2019 AT 0341. THERE WAS NO APPARENT DELAY IN ORIGINAL BOTTLE ENTRY. THE CUSTOMER REPORTS THAT THIS BOTTLE HAD A ANAEROBIC PAIR THAT WAS COLLECTED AT THE SAME TIME AND FLAGGED POSITIVE AT 0.55 DAYS. A BI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8522845 ↗
• MalfunctionAug 20, 2018Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH BACT/ALERT® SA CULTURE BOTTLE ((B)(4)). THE CUSTOMER REPORTED DURING AN API STUDY THEY INOCULATED A BACT/ALERT SN AND A BACT/ALERT SA CULTURE BOTTLE. BOTH BOTTLES REPORTED POSITIVE IN THREE (3) DAYS FOR BACILLUS SPECIES. RESULTS FOR THE STUDY WERE REPORTED AS BACILLUS; HOWEVER THE CUSTOMER EXPECTED A DIFFERENT ORGANISM THAT WAS ANAEROBIC. THERE IS NO PATIENT ASSOCIATED WITH THIS EVENT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7796946 ↗
• InjuryDec 21, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DEFORMED BACT/ALERT® SA CULTURE BOTTLE. THE CUSTOMER REPORTED THAT ONE OF THE DEFORMED BOTTLES WAS IDENTIFIED AFTER INOCULATION. THE DEFORMATION IS ON THE SIDE OF THE BOTTLE AND A CRACK WAS ALSO OBSERVED. THE CUSTOMER REPORTED HAVING TO COLLECT BLOOD FROM THE PATIENT AGAIN. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7139416 ↗
• InjuryAug 17, 2017Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF BACT/ALERT® SA CULTURE BOTTLES LEAKING POST SAMPLE COLLECTION. PER THE CUSTOMER, THE BOTTLES WERE LEAKING FROM THE CAP IN THE SAMPLE BAG. CUSTOMER STATES THE SAMPLES HAD NOT LEAKED OUTSIDE THE BAG; THEREFORE, NO STAFF MEMBERS WERE AFFECTED. THE LEAKING BACT/ALERT® CULTURE BOTTLES INITIATED MEDICAL INTERVENTION IN THE FORM OF ADDITIONAL PATIENT BLOOD DRAWS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Code Available

  MAUDE report 6802094 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020931. One submission often covers many models, so check the product and lot details in each record.

• Z-0738-2013 · Dec 25, 2012 · Terminated
  BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally