BACT/ALERT® 3D LEFT COMBINATION MODULE 200291Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03573026047573), received between Oct 16, 2019 and Nov 28, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K903505, K981736); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2022False Positive Result; False Positive Result

  INTENDED USE: THE BACT/ALERT® 3D MICROBIAL DETECTION SYSTEM IS AN AUTOMATED TEST SYSTEM CAPABLE OF INCUBATING, AGITATING, AND CONTINUOUSLY MONITORING AEROBIC AND ANAEROBIC MEDIA INOCULATED WITH PATIENT SPECIMENS SUSPECTED OF HAVING BACTEREMIA, FUNGEMIA, AND/OR MYCOBACTEREMIA. CLINICAL USE: THE FOLLOWING SPECIMEN TYPES CAN BE USED IN THE SYSTEM: BLOOD; STERILE BODY FLUIDS. INDUSTRY USE: THE SYSTEM MONITORS FOR BACTERIAL CONTAMINATION IN SAMPLES. THE BACT/ALERT® 3D MICROBIAL DETECTION SYSTEM IS INTENDED FOR LABORATORY USE BY TRAINED, PROFESSIONAL, CLINICAL AND INDUSTRY USERS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE-POSITIVE INSTRUMENT RESULTS ON THE BACT/ALERT 3D INSTRUMENT- REFERENCE 200291 (SERIAL NUMBER : (B)(4)) WHEN TESTING AN ADVANCED THERAPY MEDICINAL PRODUCT (ATMP). FOR THE MOMENT, NO INFORMATION HAS BEEN REPORTED REGARDING A POTENTIAL SUBCULTURE OF THE POSITIVE BOTTLE. 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 PATIENTS. THIS DISCREPANCY WAS REVIEWED FOR VIGILANCE REPORTING ACCORDING TO 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15867748 ↗
• MalfunctionDec 22, 2020Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING DELAYED RESULTS DUE TO AN OBSTRUCTED B SIDE DRAWER NOT OPENING FOR THE BACT/ALERT® COMBO INSTRUMENT (BTA3D COMBINATION MODULE LEFT, REF. 200291, SERIAL (B)(4)). THE CUSTOMER CALLED BIOMÉRIEUX CUSTOMER SUPPORT TO ADDRESS THE ISSUE OF THE INABILITY TO OPEN THE B SIDE DRAWER. A BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE BUT WAS UNABLE TO ARRIVE UNTIL THE NEXT DAY. IN THE MEANTIME, A PATIENT BOTTLE IN THE DRAWER ALERTED AS POSITIVE. THE CUSTOMER WAS UNABLE TO ACCESS IT. THE PATIENT DID HAVE A MATE BOTTLE, STILL SHOWING NTD (NEGATIVE TO DATE). IT WAS DETERMINED THAT A BOTTLE IN THE BOTTOM RACK WAS PREVENTING THE ABILITY TO OPEN THE DRAWER. THE CUSTOMER REMOVED THE SIDE PANEL BEFORE FSE ARRIVAL AND WAS ABLE TO PUSH THE OBSTRUCTING BOTTLE BACK INTO THE CELL, THEN OPEN THE DRAWER. THE CUSTOMER REPORTED THAT THERE WAS A POSITIVE BOTTLE ALERT AT APPROXIMATELY 1500, (B)(6) 2020. IT TOOK UNTIL 0700 ON (B)(6) 2020 FOR THE CUSTOMER TO CORRECT THE DRAWER ISSUE AND ACCESS THE POSITIVE BOTTLE, LEADING TO A DELAY IN CONFIRMING THE POSITIVE RESULT. THE POSITIVE BOTTLE WAS ON THE INSTRUMENT FOR APPROXIMAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11059505 ↗
• MalfunctionOct 16, 2019False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE NEGATIVE RESULT FOR A PATIENT SAMPLE IN ASSOCIATION WITH THE BACT/ALERT ®3D INSTRUMENT SYSTEM. THE SYSTEM INDICATED AN AEROBIC BOTTLE WAS NEGATIVE; HOWEVER, THE CUSTOMER QUESTIONED THIS RESULT BASED ON THE BOTTLE GRAPH. BLOOD CULTURE FROM THE SUSPECT BOTTLE WAS GRAM STAINED AND SHOWED PRESENCE OF GRAM-POSITIVE RODS. THE CUSTOMER STATED THIS RESULT ALIGNED WITH ANOTHER AEROBIC BOTTLE FROM THE SAME PATIENT. THIS SECOND BACT/ALERT BOTTLE FLAGGED POSITIVE AND PRESENCE OF CORYNEBACTERIUM WAS FOUND. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9199558 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K903505, K981736. One submission often covers many models, so check the product and lot details in each record.

• Z-0644-2007 · Dec 19, 2006 · Terminated
  BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box 15969, Durham, NC 27704-0969 USA
• Z-0776-2007 · Aug 14, 2006 · Terminated
  BacT/ALERT 3D 60 Systems Software, Blood Culturing System
• Z-0773-2007 · Aug 14, 2006 · Terminated
  BacT/ALERT Classic System Software, Blood Culturing System
• Z-0612-05 · May 27, 2005 · Terminated
  Bac T/ALERT 3D Control Module
• Z-0614-05 · May 27, 2005 · Terminated
  Bac T/ALERT 3D 60
• Z-0613-05 · May 27, 2005 · Terminated
  Bac T/ALERT 3D Combination Module
• Z-0456-05 · Sep 17, 2004 · Terminated
  BacT/ALERT(BTA) Classic instruments.