BACT/ALERT® PFRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03573026595722), received between May 10, 2018 and Aug 16, 2019 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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) (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/ALERT SN: LOT # 1053350

  Patient problems: Misdiagnosis

  MAUDE report 8903790 ↗
• 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 POSITIVE BOTTLE RESULTS FOR MULTIPLE PATIENTS BETWEEN (B)(6) 2019. THE BOTTLES GREW STAPHYLOCOCCUS AUREUS. 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 POSITIVE 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, EX

  Patient problems: Misdiagnosis

  MAUDE report 8903778 ↗
• MalfunctionDec 14, 2018Contamination; Contamination

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT® PF (REFERENCE 259794). THE CUSTOMER REPORTED THAT ELEVEN BOTTLES WERE IMPACTED BY A POTENTIAL CONTAMINATION ISSUE OF BACILLUS CEREUS SPECIES (5 FA PLUS BOTTLES, 4 FN PLUS BOTTLES AND 2 PF PLUS BOTTLES). THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8166001 ↗
• MalfunctionAug 8, 2018False Negative Result; False Negative Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS ASSOCIATED WITH BACT/ALERT® SN CULTURE BOTTLE (REFERENCE 259790). THE CUSTOMER REPORTED THAT TWO PRODUCTS (REFERENCE NUMBERS 259790 AND 259794) FAILED QUALITY CONTROL (QC) TESTING AT THE SAME TIME WHILE OTHER BOTTLES PASSED THE SAME TESTING. THERE IS NOT PATIENT ASSOCIATED WITH THIS QUALITY CONTROL TESTING. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7763470 ↗
• MalfunctionMay 10, 2018False Negative Result; False Negative Result

  A STUDY WAS CONDUCTED BY (B)(4) TO ASSESS THE DIFFERENT CAPACITY OF BTA SYSTEM TO DETECT THE PRESENCE OF MALASSEZIA SPP. IN PRENATAL BSIS. THE STUDY HIGHLIGHTS AN ISSUE WITH BIOMÉRIEUX BACT/ALERT® FA AND PF BOTTLES IN DETECTING MALASSEZIA FURFUR IN BLOOD STREAM INFECTIONS. FROM THE ABSTRACT: "THE OCCURRENCE OF MALASSEZIA SPP. BLOODSTREAM INFECTIONS (B5IS) IN NEONATAL INTENSIVE CARE UNIT WAS EVALUATED BY USING PEDIATRIC ISOLATOR, BACT/ALERT® SYSTEMS AND CENTRAL VENOUS CATHETER (CVC) CULTURE. THE EFFICACY OF BACT/ALERT® SYSTEM IN DETECTING MALASSEZIA WAS ASSESSED BY CONVENTIONAL PROCEDURES, CULTURING 1 ML OF BOTTLE CONTENT BEFORE INCUBATION AND BY STUDYING THE SURVIVAL OF MALASSEZIA SPP. STRAINS IN BACT/ALERT® BOTTLES. ONLY ONE PATIENT (0.5%) FROM GROUP IL SCORED POSITIVE FOR M. FURFUR ALSO BY CULTURING IN DIXA 1 ML BLOOD CONTENT OF BACT/ALERT® BOTTLE BEFORE INCUBATION IN BACT/ALERT SYSTEM. M. FURFUR POPULATION SIZE IN BACT/ALERT BOTTLES DECREASED DURING THE INCUBATION TIME, WHEREAS THAT OF M. PACHYDERMATIS INCREASED. THE BACT/ALERT SYSTEM DETECTED M. PACHYDERMATIS EVEN AT VERY LOW CONCENTRATION (I.E., 10 CFU/ML) BUT NOT ANY POSITIVE BLOOD CULTURE FOR M. FURFUR. FOR A CORRECT DIAGNOS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7501908 ↗