BACT/ALERT® 3D RIGHT INCUBATION MODULE 210161Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03573026049591), received between Jul 21, 2017 and Oct 14, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Negative 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2021False Positive Result; False Positive Result

  INTENDED USE: THE BACT/ALERT® 3D LOW TEMPERATURE (LT) MODULE IS PART OF THE BACT/ALERT® 3D DUAL-T SYSTEM, WHICH IS AN AUTOMATED MICROBIAL DETECTION TEST SYSTEM CAPABLE OF INCUBATING, AGITATING, AND CONTINUOUSLY MONITORING AEROBIC AND ANAEROBIC CULTURE MEDIA. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® 3D DUAL-T SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. DESCRIPTION OF THE PROBLEM: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF AN INCREASED RATE OF FALSE POSITIVE CULTURE BOTTLE RESULTS IN ASSOCIATION WITH THE BACT/ALERT 3D SYSTEM (REF. (B)(4), SERIAL NUMBER (B)(4)). THE CUSTOMER STATED THE FALSE POSITIVE RESULTS ARE NOT ISOLATED TO A SPECIFIC BOTTLE TYPE OR LOT. THE CUSTOMER INDICATED THEY ARE USING BPA AND BPN BOTTLES PREDOMINANTLY, FOR PLATELET SAMPLES. THE CUSTOMER CURRENTLY HAS ONLY ONE INCUBATOR MODULE AVAILABLE DUE TO A VALIDATION PROCESS, AND DID NOT HAVE THE COLD BOTTLE COMPENSATION FILTER ENABLED. THE HIGH VOLUME OF BOTTLE LOADING COUPLED WITH THE SINGLE INCUBATOR, AND NO COMPENSATION FILTER, IS A LIKELY CAUSE OF THE FALSE POSITIVE BOTTLE RESULTS. THE CUSTOMER INDICATED NO VISIBLE GROWTH IN THE BOTTLES, GRAM STAINS ARE NEGATIVE. THE CUST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632622 ↗
• MalfunctionSep 27, 2021Fire; Mechanical Problem; Fire; Mechanical Problem

  INTENDED USE: THE BACT/ALERT¿ 3D LOW TEMPERATURE (LT) MODULE IS PART OF THE BACT/ALERT¿ 3D DUAL-T SYSTEM, WHICH IS AN AUTOMATED MICROBIAL DETECTION TEST SYSTEM CAPABLE OF INCUBATING, AGITATING, AND CONTINUOUSLY MONITORING AEROBIC AND ANAEROBIC CULTURE MEDIA. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT¿ 3D DUAL-T SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. DESCRIPTION OF THE PROBLEM A CUSTOMER IN (B)(6) NOTIFIED BIOM¿RIEUX OF OVERHEATING AT THE POWER INPUT AND A START OF FIRE IN ASSOCIATION WITH INCUBATOR MOD RGHT W/RACKS 3D (REF. 210161, SERIAL NUMBER (B)(4) ) WHICH IS PART OF BACT/ALERT¿ SYSTEM. THE CUSTOMER REPORTED THAT THE EQUIPMENT PRESENTED OVERHEATING AT THE POWER INPUT AND THERE WAS A START OF FIRE THAT WAS EXTINGUISHED BY THE OPERATORS WITH A FIRE EXTINGUISHER. BIOM¿RIEUXS CUSTOMER SERVICE REPORTED THAT THIS HAPPENED ONLY ON THE INCUBATOR MODULE AND THE ISSUE WAS SOLVED BY REPLACING THE POWER ENTRY REF. 805-0017-02. THE INCUBATOR IS CONNECTED TO A SMART UPS APC 1500. THE POWER CORD WAS UNPLUGGED IMMEDIATELY AND THE CUSTOMER USED A FIRE EXTINGUISHER. IT HAS BEEN REPORTED THAT THERE WERE NO PATIENT/USER HARM NOR INJURY. FOLLOWING REPAIR BY BIOM¿RI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533385 ↗
• MalfunctionMay 1, 2020False Negative Result; False Negative Result

  AN INDUSTRY CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF OBTAINING A FALSE NEGATIVE RESULT WHILE TESTING CORD BLOOD USING THE BACT/ALERT® SN BLOOD CULTURE BOTTLE (REF. 259790, LOT 1053744) AND THE BACT/ALERT® 3D INSTRUMENT (REF. 210161, SERIAL (B)(4)). THE CUSTOMER STATED THE BACT/ALERT® SN BLOOD CULTURE BOTTLE WAS INCUBATED FOR FOURTEEN (14) DAYS AND OBTAINED NEGATIVE RESULT ON BACT/ALERT® 3D INSTRUMENT. HOWEVER, UPON REMOVAL OF THE BOTTLE FROM THE INSTRUMENT, THE CUSTOMER NOTICED THE BOTTLE CONTENTS WERE TURBID AND THE SENSOR WAS YELLOW. THE CUSTOMER SUBCULTURED AND IDENTIFIED THE BOTTLE CONTENTS. AN IDENTIFICATION OF CLOSTRIDIUM CLOSTRIDIOFORME WAS OBTAINED. BIOMERIEUX CUSTOMER SERVICE REVIEWED THE BOTTLE GRAPH DATA AND DETERMINED THE GRAPH IS FLAT UNTIL DAY FIVE (5), THEN BEGAN TO INCREASE SLOWLY OVER THE NEXT THREE (3) DAYS WITH ANOTHER INCREASE AT DAY TWELVE (12). HOWEVER, THE GROWTH WAS NOT SUFFICIENT TO TRIGGER THE ALGORITHM TO FLAG THE BOTTLE POSITIVE. THERE WAS NO PATIENT INVOLVEMENT AS THIS IS AN INDUSTRY CUSTOMER; THEREFORE THERE IS NO ADVERSE IMPACT TO ANY PATIENT'S STATE OF HEALTH. BIOMERIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 10018847 ↗
• MalfunctionJul 21, 2017Smoking; Smoking

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF SMOKE COMING FROM THE BACT/ALERT® UNIT AT THEIR SITE. THEY ATTEMPTED TO MOVE THE BOTTLES TO ANOTHER INCUBATOR, BUT WHEN THEY WOULD PUT THE BOTTLES INTO A NEW CELL, THEY GET A 913 ERROR. THEY WERE INSTRUCTED TO TURN OFF AND UNPLUG THE INCUBATOR WHILE AWAITING A FIELD SERVICE ENGINEER TO COME TO THE SITE. THEY WERE INSTRUCTED TO FOLLOW DOWNTIME PROCEDURES AND SUBCULTURE THE BOTTLES. THE CUSTOMER STATES 203 BOTTLES HAD TO BE SUBCULTURED. OF THESE, 65 SUBCULTURES WERE DELAYED DUE TO RUNNING OUT OF SYRINGES. THIS DELAY WAS DESCRIBED AS BEING 24 HOURS OR LESS. THE CUSTOMER STATES THAT THERE WAS NO DELAY IN GETTING TEST RESULTS OUT. NUMBER OF SPECIMEN BOTTLES WERE KNOWN, BUT THERE WAS NO INDICATION FROM THE CUSTOMER OF THE NUMBER OF PATIENTS ASSOCIATED. THE CUSTOMER ALSO REPORTS THAT NO INJURIES OCCURRED DUE TO THE SMOKE ISSUES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6734107 ↗

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-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-0612-05 · May 27, 2005 · Terminated
  Bac T/ALERT 3D Control Module
• Z-0456-05 · Sep 17, 2004 · Terminated
  BacT/ALERT(BTA) Classic instruments.