BACT/ALERT® FARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03573026595906), received between Oct 13, 2017 and Aug 6, 2019 — classified as 5 malfunctions.

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

3 other recalls cover devices cleared under the same FDA submission (K020813); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 8864489 ↗
• MalfunctionSep 18, 2018False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT ASSOCIATED WITH THE BACT/ALERT® FA BLOOD CULTURE BOTTLE (REFERENCE (B)(4)). THE CUSTOMER CULTURED BLOOD FROM ONE PATIENT INTO ONE (1) BACT/ALERT FA AND ONE (1) BACT/ALERT FN BOTTLE. THE BACT/ALERT FA BOTTLE (BOTTLE ID ARRHZHFD) PRODUCED A NEGATIVE RESULT AND THE BACT/ALERT FN BOTTLE (BOTTLE ID NRR0PPBX) PRODUCED A POSITIVE RESULT. BOTH BOTTLES WERE SUBCULTURED AND BOTH SUBCULTURES GAVE AN IDENTIFICATION OF PSEUDOMONAS FROM VITEK® MS INSTRUMENT. 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 7884866 ↗
• MalfunctionMay 10, 2018False Negative Result; False Negative Result

  A STUDY WAS CONDUCTED BY (B)(6) 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. FURFURPOPULATION 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 DIAGNOSI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7501909 ↗
• MalfunctionOct 13, 2017Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT BACILLUS CONTAMINATION ASSOCIATED WITH A BACT/ALERT® FA PLUS CULTURE BOTTLES. THE CULTURE BOTTLE PROVIDED A POSITIVE RESULT WITHIN ONE DAY AFTER SAMPLE COLLECTION. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6949944 ↗
• MalfunctionOct 13, 2017Contamination; Contamination

  A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT BACILLUS CONTAMINATION ASSOCIATED WITH A BACT/ALERT® FA PLUS CULTURE BOTTLES. THE CULTURE BOTTLE PROVIDED A POSITIVE RESULT WITHIN ONE DAY AFTER SAMPLE COLLECTION. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6949814 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020813. One submission often covers many models, so check the product and lot details in each record.

• Z-0750-2016 · Dec 24, 2015 · Terminated
  BacT/ALERT FA, bioMrieux, Inc., Product Usage: BacT/ALERT Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery a
• Z-2244-2011 · Apr 13, 2011 · Terminated
  BacT/ALERT - FA Reagent Bottle The BacT/ALERT Microbial Detection System is used to determine if microorganisms are present in blood or other normally sterile body fluid samples ta
• Z-0643-2007 · Jan 11, 2007 · Terminated
  BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704