BACT/ALERT® 3D LEFT INCUBATION MODULE 210159Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03573026049577), received between Nov 11, 2021 and Aug 23, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (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 18, 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.

• InjuryAug 23, 2024Noise, Audible; Noise, Audible

  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. THE BACT/ALERT® 3D MICROBIAL DETECTION SYSTEM IS INTENDED FOR LABORATORY USE BY TRAINED, PROFESSIONAL, CLINICAL AND INDUSTRY USERS. ISSUE DESCRIPTION: A BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) IN THE UNITED STATES WAS DIAGNOSING A PROBLEM ON A BACT/ALERT® 3D INCUBATOR WHEN HE SUSTAINED AN INJURY TO THE MIDDLE FINGER OF HIS LEFT HAND. THE FSE WAS DIAGNOSING A BACT/ALERT® 3D INCUBATOR THAT WAS MAKING CLUNKING NOISES FROM THE AGITATION SYSTEM. HE HAD JUST BEGUN DIAGNOSIS AND HAD COVERS OFF OF THE UNIT WHILE LISTENING IN AN EFFORT TO PINPOINT THE SOURCE OF THE NOISE. DURING THAT PROCESS, HE HAD HIS HAND TOO CLOSE TO THE DRIVE BELT WHICH CAUGHT HIS FINGER AND PINCHED IT BETWEEN THE BELT AND PULLEY, CAUSING THE INJURY. CUSTOMER RANA SARHAN (MICROBIOLOGY SUPERVISOR) TOOK THE FSE TO THE EMERGENCY ROOM. IT WAS DETERMINED THAT THE INJURY RESULTED IN DAMAGE TO THE TIP OF HIS FINGER. IT WAS DESCRIBED AS A BONE FRACTURE WI

  Patient problems: Crushing Injury

  MAUDE report 20057168 ↗
• MalfunctionDec 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INDUSTRY CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF A FALSE POSITIVE RESULT IN ASSOCIATION WITH THEIR BACT/ALERT® INCUBATOR MOD LEFT W/RACKS 3D (REF. 210159, SERIAL # (B)(4)) WHEN TESTING ADVANCED THERAPY MEDICAL PRODUCT (ATMP). THE CUSTOMER STATED TWO (2) IFA PLUS CULTURE BOTTLES WERE DECLARED POSITIVE; HOWEVER, WHEN REVIEWING THE BOTTLE GRAPHS THE GROWTH CURVES WERE FLAT. ONE (1) BOTTLE WAS SUB-CULTURED AND GRAM-STAINED. THE CUSTOMER STATED THEY MAY HAVE OBSERVED GRAM-POSITIVE COCCI; HOWEVER, THIS WAS UNCONFIRMED AS NO ORGANISMS WERE PRESENT ON THE GRAM SLIDES. BIOMÉRIEUX CUSTOMER SERVICE HAS REQUESTED THE BOTTLE SUBCULTURE RESULTS FOR BOTH IMPACTED BOTTLES. AS THERE IS NO PATIENT ASSOCIATED WITH THIS SAMPLE, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL OPEN AN INTERNAL INVESTIGATION FOR THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13111082 ↗
• MalfunctionNov 11, 2021False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF EXPERIENCING AN INCREASE IN FALSE POSITIVE RESULTS WHILE TESTING BLOOD PLATELET SAMPLES IN ASSOCIATION WITH THEIR BACT/ALERT® INCUBATOR MOD LEFT W/RACKS 3D (REF 210159, SERIAL (B)(4)). THE CUSTOMER CLAIMED THAT THEY HAVE EXPERIENCED A 500% INCREASE IN FALSE POSITIVE RESULTS. OF THIRTY-SIX (36) POSITIVE BOTTLES THE CUSTOMER WAS TRACKING, SEVEN (7) WERE CONFIRMED TO BE TRUE POSITIVES. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER FOR TROUBLESHOOTING PURPOSES. AT THE TIME OF THIS ASSESSMENT, NO ADDITIONAL INFORMATION OF BACKUP FILES HAVE BEEN RECEIVED FROM THE CUSTOMER. 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. AN INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12797752 ↗

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-0613-05 · May 27, 2005 · Terminated
  Bac T/ALERT 3D Combination Module
• Z-0614-05 · May 27, 2005 · Terminated
  Bac T/ALERT 3D 60
• Z-0456-05 · Sep 17, 2004 · Terminated
  BacT/ALERT(BTA) Classic instruments.