BACT/ALERT® 3D CONTROL MODULE 210147Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 03573026049522), received between Mar 31, 2017 and Dec 22, 2023 — classified as 1 death, 17 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (10 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2023False Negative Result; False Negative Result

  PRODUCT DESCRIPTION. 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. COMPLAINT DESCRIPTION. A CUSTOMER IN PORTUGAL COMPLAINED AFTER HAVING OBTAINED FALSE NEGATIVE RESULTS WHEN TESTING FOUR BACT/ALERT® BOTTLES (TWO FA PLUS AND TWO FN PLUS) INOCULATED WITH ONE PATIENT SAMPLE IN ASSOCIATION WITH THEIR CONTROL MODULE PKGD 3D (REF (B)(4), SERIAL (B)(6). THE CUSTOMER INDICATED THAT THEY HAD INSPECTED THE BOTTLES UNLOADED AFTER FIVE DAYS' OF INCUBATION AND THE SENSOR WAS NOT YELLOW. LOT INFORMATION OF THE FA PLUS AND FN PLUS WERE NOT AVAILABLE AT THE TIME OF THIS GLOBAL ASSEMENT. THE CUSTOMER SAID THAT BEFORE INCUBATING THE BOTTLES INOCULATED WITH THE PATIENT'S SAMPLE IN THEIR BACT ALERT INSTRUMENT, THEY HAD SUBCULTERED THE CONTENT OF THE BOTTLES ONTO DIFFERENT MEDIA (TODD HEWITT, COLUMBIA BLOOD AGAR AND POLYVITEX CHOCOLATE) AND THAT AFTER INCUBATION THEY HAD OBSERVED A BACTERIAL GROWTH THAT WAS IDENTIFIED AS STREPTOCOCCUS PNEUMONIAE. NO FURTHER DETAILS WERE PROVIDED. THE CUSTO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18381963 ↗
• MalfunctionOct 7, 2022False Negative Result; False Negative 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. DESCRIPTION: A CUSTOMER IN INDIA NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULTS FOR MULTIPLE BACT/ALERT® BOTTLES (FN PLUS AND FA PLUS) IN ASSOCIATION WITH THE CONTROL MODULE PKGD 3D (REF 210147, SERIAL (B)(4). THE CUSTOMER PROVIDED DETAILS FOR 13 BOTTLES FOR WHICH THE SENSORS HAD TURNED YELLOW (INDICATING A POSITIVE BOTTLE), BUT THE INSTRUMENT DID NOT FLAG THE BOTTLES AS POSITIVE. GRAM STAINING RESULTS WERE PROVIDED FOR 11 BOTTLES, AND IDENTIFICATIONS OF RECOVERED ORGANISMS WERE PROVIDED FOR 9 BOTTLES. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE FALSE NEGATIVE RESULTS HAVE LED TO OR CONTRIBUTED TO A DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR ANY PATIENT. AN INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15562760 ↗
• MalfunctionAug 16, 2022Defective Component; Defective Component

  INTENDED USE: BACT/ALERT® VIRTUO® MICROBIAL DETECTION SYSTEM IS AN AUTOMATED MICROBIAL TEST SYSTEM CAPABLE OF INCUBATING, AGITATING, AND CONTINUOUSLY MONITORING FOR THE DETECTION OF AEROBIC, FACULTATIVE, AND ANAEROBIC MICROORGANISM GROWTH FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS AND FROM BLOOD PLATELET SAMPLES. ISSUE DESCRIPTION: A CUSTOMER (BLOOD BANK) IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF A POTENTIAL INSTRUMENT FALSE POSITIVE RESULT IN ASSOCIATION WITH CONTROL MODULE PKGD 3D (REF. 210147, SERIAL NUMBER (B)(4)) WHICH IS PART OF BACT/ALERT® VIRTUO® SYSTEM. IT WAS REPORTED THAT A BLOOD CENTER CUSTOMER EXPERIENCED A POSITIVE RESULT ON A SAMPLE. THE RESULT HAS NOT BEEN CONFIRMED AS POSITIVE AND THE CUSTOMER STATED THE SUBCULTURE CONFIRMATION MAY TAKE A FEW WEEKS TO RECEIVE. IT WAS REPORTED THAT ONCE A SAMPLE BECOMES A POSITIVE ON THE BACT/ALERT® SYSTEM, SIGNAPPS EMAILS ARE SENT AUTOMATICALLY TO BACTERIAL SCREENING AND THE ISSUING DEPARTMENT AND THIS TRIGGERS THE RECALL PROCESS, SO IT WAS CONFIRMED THAT THIS FALSE POSITIVE HAS BEEN RECALLED. HOWEVER, RECOVERING THE PLATELET UNITS FOR THEM TO BE SENT FOR BACTERIOLOGY TESTING IS DEPENDENT ON THEIR LOCATION AT THE TIME OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234101 ↗
• MalfunctionMay 5, 2022False 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 CULTURE MEDIA. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® 3D DUAL-T SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX AFTER OBTAINING FALSE POSITIVE RESULTS FOR PLATELET SAMPLES IN ASSOCIATION WITH BACT/ALERT CONTROL MODULE 3D (REF. 210147, SERIAL NUMBER. (B)(4)). THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE RESULTS WITH BPA AND BPN BOTTLE TYPES WHEN TESTING PLATELET SAMPLES. THE CUSTOMER OBSERVED AN INCREASE OF THE NUMBER OF FALSE POSITIVE BOTTLES IN (B)(6) 2022 (10 BOTTLES). THE FALSE POSITIVE BOTTLES ARE NOT CONFINED TO ONE DRAWER OR INCUBATOR, AND THE CUSTOMER LOADED DIFFERENT DRAWERS FOR EACH BOTTLE. BIOMÉRIEUX CUSTOMER SERVICE HAD NOTICED AFTER DISCUSSION WITH THE CUSTOMER THAT TECHNICIANS MAY BE INOCULATING THE BOTTLE SAMPLES OUT OF ORDER (BPN THEN BPA). INSTRUCTIONS FOR USE INDICATE THE BPA BOTTLE SHOULD BE INOCULATED FIRST, THEN THE BPN BOTTLE; THIS TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285282 ↗
• MalfunctionMay 5, 2022False 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 CULTURE MEDIA. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® 3D DUAL-T SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX AFTER OBTAINING FALSE POSITIVE RESULTS FOR PLATELET SAMPLES IN ASSOCIATION WITH BACT/ALERT CONTROL MODULE 3D (REF. 210147, SERIAL NUMBER. (B)(4). THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE RESULTS WITH BPA AND BPN BOTTLE TYPES WHEN TESTING PLATELET SAMPLES. THE CUSTOMER OBSERVED AN INCREASE OF THE NUMBER OF FALSE POSITIVE BOTTLES IN (B)(6) 2022 (10 BOTTLES). THE FALSE POSITIVE BOTTLES ARE NOT CONFINED TO ONE DRAWER OR INCUBATOR, AND THE CUSTOMER LOADED DIFFERENT DRAWERS FOR EACH BOTTLE. BIOMÉRIEUX CUSTOMER SERVICE HAD NOTICED AFTER DISCUSSION WITH THE CUSTOMER THAT TECHNICIANS MAY BE INOCULATING THE BOTTLE SAMPLES OUT OF ORDER (BPN THEN BPA). INSTRUCTIONS FOR USE INDICATE THE BPA BOTTLE SHOULD BE INOCULATED FIRST, THEN THE BPN BOTTLE; THIS TO P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285272 ↗
• MalfunctionMay 5, 2022False 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 CULTURE MEDIA. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® 3D DUAL-T SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX AFTER OBTAINING FALSE POSITIVE RESULTS FOR PLATELET SAMPLES IN ASSOCIATION WITH BACT/ALERT CONTROL MODULE 3D (REF. 210147, SERIAL NUMBER. (B)(4). THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE RESULTS WITH BPA AND BPN BOTTLE TYPES WHEN TESTING PLATELET SAMPLES. THE CUSTOMER OBSERVED AN INCREASE OF THE NUMBER OF FALSE POSITIVE BOTTLES IN MARCH 2022 (10 BOTTLES). THE FALSE POSITIVE BOTTLES ARE NOT CONFINED TO ONE DRAWER OR INCUBATOR, AND THE CUSTOMER LOADED DIFFERENT DRAWERS FOR EACH BOTTLE. BIOMÉRIEUX CUSTOMER SERVICE HAD NOTICED AFTER DISCUSSION WITH THE CUSTOMER THAT TECHNICIANS MAY BE INOCULATING THE BOTTLE SAMPLES OUT OF ORDER (BPN THEN BPA). INSTRUCTIONS FOR USE INDICATE THE BPA BOTTLE SHOULD BE INOCULATED FIRST, THEN THE BPN BOTTLE; THIS TO PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285233 ↗
• MalfunctionMay 5, 2022False 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 CULTURE MEDIA. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® 3D DUAL-T SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX AFTER OBTAINING FALSE POSITIVE RESULTS FOR PLATELET SAMPLES IN ASSOCIATION WITH BACT/ALERT CONTROL MODULE 3D (REF. 210147, SERIAL NUMBER. (B)(4)). THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE RESULTS WITH BPA AND BPN BOTTLE TYPES WHEN TESTING PLATELET SAMPLES. THE CUSTOMER OBSERVED AN INCREASE OF THE NUMBER OF FALSE POSITIVE BOTTLES IN (B)(6) 2022 (10 BOTTLES). THE FALSE POSITIVE BOTTLES ARE NOT CONFINED TO ONE DRAWER OR INCUBATOR, AND THE CUSTOMER LOADED DIFFERENT DRAWERS FOR EACH BOTTLE. BIOMÉRIEUX CUSTOMER SERVICE HAD NOTICED AFTER DISCUSSION WITH THE CUSTOMER THAT TECHNICIANS MAY BE INOCULATING THE BOTTLE SAMPLES OUT OF ORDER (BPN THEN BPA). INSTRUCTIONS FOR USE INDICATE THE BPA BOTTLE SHOULD BE INOCULATED FIRST, THEN THE BPN BOTTLE; THIS TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285228 ↗
• MalfunctionMay 5, 2022False 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 CULTURE MEDIA. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® 3D DUAL-T SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX AFTER OBTAINING FALSE POSITIVE RESULTS FOR PLATELET SAMPLES IN ASSOCIATION WITH BACT/ALERT CONTROL MODULE 3D (REF. 210147, SERIAL NUMBER. (B)(4). THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE RESULTS WITH BPA AND BPN BOTTLE TYPES WHEN TESTING PLATELET SAMPLES. THE CUSTOMER OBSERVED AN INCREASE OF THE NUMBER OF FALSE POSITIVE BOTTLES IN MARCH 2022 (10 BOTTLES). THE FALSE POSITIVE BOTTLES ARE NOT CONFINED TO ONE DRAWER OR INCUBATOR, AND THE CUSTOMER LOADED DIFFERENT DRAWERS FOR EACH BOTTLE. BIOMÉRIEUX CUSTOMER SERVICE HAD NOTICED AFTER DISCUSSION WITH THE CUSTOMER THAT TECHNICIANS MAY BE INOCULATING THE BOTTLE SAMPLES OUT OF ORDER (BPN THEN BPA). INSTRUCTIONS FOR USE INDICATE THE BPA BOTTLE SHOULD BE INOCULATED FIRST, THEN THE BPN BOTTLE; THIS TO PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285216 ↗
• MalfunctionMay 5, 2022False 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 CULTURE MEDIA. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® 3D DUAL-T SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX AFTER OBTAINING FALSE POSITIVE RESULTS FOR PLATELET SAMPLES IN ASSOCIATION WITH BACT/ALERT CONTROL MODULE 3D (REF. 210147, SERIAL NUMBER. (B)(4)). THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE RESULTS WITH BPA AND BPN BOTTLE TYPES WHEN TESTING PLATELET SAMPLES. THE CUSTOMER OBSERVED AN INCREASE OF THE NUMBER OF FALSE POSITIVE BOTTLES IN (B)(6) 2022 (10 BOTTLES). THE FALSE POSITIVE BOTTLES ARE NOT CONFINED TO ONE DRAWER OR INCUBATOR, AND THE CUSTOMER LOADED DIFFERENT DRAWERS FOR EACH BOTTLE. BIOMÉRIEUX CUSTOMER SERVICE HAD NOTICED AFTER DISCUSSION WITH THE CUSTOMER THAT TECHNICIANS MAY BE INOCULATING THE BOTTLE SAMPLES OUT OF ORDER (BPN THEN BPA). INSTRUCTIONS FOR USE INDICATE THE BPA BOTTLE SHOULD BE INOCULATED FIRST, THEN THE BPN BOTTLE; THIS TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285202 ↗
• MalfunctionMay 5, 2022False 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 CULTURE MEDIA. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® 3D DUAL-T SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX AFTER OBTAINING FALSE POSITIVE RESULTS FOR PLATELET SAMPLES IN ASSOCIATION WITH BACT/ALERT CONTROL MODULE 3D (REF. (B)(4), SERIAL NUMBER. (B)(4)). THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE RESULTS WITH BPA AND BPN BOTTLE TYPES WHEN TESTING PLATELET SAMPLES. THE CUSTOMER OBSERVED AN INCREASE OF THE NUMBER OF FALSE POSITIVE BOTTLES IN (B)(6) 2022 (10 BOTTLES). THE FALSE POSITIVE BOTTLES ARE NOT CONFINED TO ONE DRAWER OR INCUBATOR, AND THE CUSTOMER LOADED DIFFERENT DRAWERS FOR EACH BOTTLE. BIOMÉRIEUX CUSTOMER SERVICE HAD NOTICED AFTER DISCUSSION WITH THE CUSTOMER THAT TECHNICIANS MAY BE INOCULATING THE BOTTLE SAMPLES OUT OF ORDER (BPN THEN BPA). INSTRUCTIONS FOR USE INDICATE THE BPA BOTTLE SHOULD BE INOCULATED FIRST, THEN THE BPN BOTTLE; THIS TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285200 ↗
• MalfunctionMay 5, 2022False 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 CULTURE MEDIA. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® 3D DUAL-T SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX AFTER OBTAINING FALSE POSITIVE RESULTS FOR PLATELET SAMPLES IN ASSOCIATION WITH BACT/ALERT CONTROL MODULE 3D (REF. 210147, SERIAL NUMBER. (B)(4)). THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE RESULTS WITH BPA AND BPN BOTTLE TYPES WHEN TESTING PLATELET SAMPLES. THE CUSTOMER OBSERVED AN INCREASE OF THE NUMBER OF FALSE POSITIVE BOTTLES IN (B)(6) 2022 (10 BOTTLES). THE FALSE POSITIVE BOTTLES ARE NOT CONFINED TO ONE DRAWER OR INCUBATOR, AND THE CUSTOMER LOADED DIFFERENT DRAWERS FOR EACH BOTTLE. BIOMÉRIEUX CUSTOMER SERVICE HAD NOTICED AFTER DISCUSSION WITH THE CUSTOMER THAT TECHNICIANS MAY BE INOCULATING THE BOTTLE SAMPLES OUT OF ORDER (BPN THEN BPA). INSTRUCTIONS FOR USE INDICATE THE BPA BOTTLE SHOULD BE INOCULATED FIRST, THEN THE BPN BOTTLE; THIS TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285157 ↗
• MalfunctionMay 5, 2022False 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 CULTURE MEDIA. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® 3D DUAL-T SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX AFTER OBTAINING FALSE POSITIVE RESULTS FOR PLATELET SAMPLES IN ASSOCIATION WITH BACT/ALERT CONTROL MODULE 3D (REF. (B)(4), SERIAL NUMBER. (B)(4)). THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE RESULTS WITH BPA AND BPN BOTTLE TYPES WHEN TESTING PLATELET SAMPLES. THE CUSTOMER OBSERVED AN INCREASE OF THE NUMBER OF FALSE POSITIVE BOTTLES IN (B)(6) 2022 (10 BOTTLES). THE FALSE POSITIVE BOTTLES ARE NOT CONFINED TO ONE DRAWER OR INCUBATOR, AND THE CUSTOMER LOADED DIFFERENT DRAWERS FOR EACH BOTTLE. BIOMÉRIEUX CUSTOMER SERVICE HAD NOTICED AFTER DISCUSSION WITH THE CUSTOMER THAT TECHNICIANS MAY BE INOCULATING THE BOTTLE SAMPLES OUT OF ORDER (BPN THEN BPA). INSTRUCTIONS FOR USE INDICATE THE BPA BOTTLE SHOULD BE INOCULATED FIRST, THEN THE BPN BOTTLE; THIS TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285149 ↗
• MalfunctionMay 5, 2022False 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 CULTURE MEDIA. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® 3D DUAL-T SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX AFTER OBTAINING FALSE POSITIVE RESULTS FOR PLATELET SAMPLES IN ASSOCIATION WITH BACT/ALERT CONTROL MODULE 3D (REF. 210147, SERIAL NUMBER. (B)(4). THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE RESULTS WITH BPA AND BPN BOTTLE TYPES WHEN TESTING PLATELET SAMPLES. THE CUSTOMER OBSERVED AN INCREASE OF THE NUMBER OF FALSE POSITIVE BOTTLES IN (B)(6) 2022 (10 BOTTLES). THE FALSE POSITIVE BOTTLES ARE NOT CONFINED TO ONE DRAWER OR INCUBATOR, AND THE CUSTOMER LOADED DIFFERENT DRAWERS FOR EACH BOTTLE. BIOMÉRIEUX CUSTOMER SERVICE HAD NOTICED AFTER DISCUSSION WITH THE CUSTOMER THAT TECHNICIANS MAY BE INOCULATING THE BOTTLE SAMPLES OUT OF ORDER (BPN THEN BPA). INSTRUCTIONS FOR USE INDICATE THE BPA BOTTLE SHOULD BE INOCULATED FIRST, THEN THE BPN BOTTLE; THIS TO P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285147 ↗
• MalfunctionMar 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF EXPERIENCING AN ISSUE WITH THEIR BACT/ALERT® CONTROL MODULE PKGD 3D (REF 210147, SERIAL (B)(4)) IN WHICH THE CUSTOMER CLAIMS THE INSTRUMENT TRANSMITTED NEGATIVE RESULTS FOR TWO CULTURE BOTTLES THAT HAD FLAGGED AS POSITIVE. THE CUSTOMER IS REPORTING THAT THE INSTRUMENT IS SENDING INFO TO THE CUSTOMER'S LABORATORY INFORMATION SYSTEM (LIS) AND IT THEN UPDATES THE REPORT 'NEGATIVE AT 24 HOURS' BEFORE THE BOTTLES HAVE REACHED ONE DAY OF INCUBATION. BOTTLE IDS NRWZFZZ4 AND ARX5SBZP BOTH FLAGGED POSITIVE ON THE INSTRUMENT IN LESS THAN 24 HOURS AFTER BEING PUT ON TEST, BUT THE CUSTOMER'S LABORATORY INFORMATION SYSTEM (LIS) REPORTED THAT THE BOTTLES WERE BOTH "NEGATIVE TO DATE" AT 24 HOURS. DUE TO THIS ISSUE, THE CUSTOMER STATED THAT THE INCORRECT RESULTS WERE RELEASED WHEN THE NEGATIVE RESULTS AT 24 HOURS WERE RELEASED. THE PATIENT HAD CEASED ANTIBIOTIC TREATMENT, BUT THE TREATMENT CHANGE HAS NOT BEEN CONFIRMED TO BE A DIRECT RESULT OF THE RELEASE OF THE NEGATIVE RESULTS AT 24 HOURS. THE PATIENT WAS PLACED BACK ON ANTIBIOTIC THERAPY WHEN THE POSITIVE BLOOD CULTURE RESULTS WERE COMMUNICATED TO THE TREATING PHYSICIAN. IT IS REPORTED THAT THE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563060 ↗
• MalfunctionJan 15, 2020Missing Test Results; Missing Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF MISSING DATA AND BOTTLE GRAPHS FROM (B)(6) 2019 TO (B)(6) 2019 WHEN USING THE BACT/ALERT® 3D SYSTEM (REF. 210147, SERIAL (B)(4)). BIOMÉRIEUX DISPATCHED A FIELD SERVICE ENGINEER TO TROUBLESHOOT THE ISSUE ON-SITE. THE FLASH DISK WAS CONFIRMED TO BE CORRUPTED, WHICH CAUSED THE REPORTED DATA ISSUE. THE FLASH DISK AND CPU BOARD WERE REPLACED TO CORRECT THE ISSUE. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN RESULTS GREATER THAN EIGHT (8) HOURS. THEY DISCARDED THE BOTTLES IMPACTED BY THIS DATA LOSS AS THEY DID NOT KNOW IF THE RESULTS WERE VALID. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INJURY OR HARM DUE TO THIS ISSUE. THE CUSTOMER IS (B)(6) BLOOD & TRANSPLANT. IT IS NOT SPECIFIED IF THE IMPACTED BOTTLE TESTING WAS FOR QUALITY CONTROL TESTING PERFORMED FOR PRODUCT AWAITING RELEASE PRIOR TO END OF TESTING OR AFTER END OF TESTING. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9593570 ↗
• MalfunctionMay 7, 2018False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS ASSOCIATED WITH BACT/ALERT® 3D INSTRUMENT (REFERENCE 210147). THE CUSTOMER INOCULATED THE BOTTLE OF 5ML OF UMBILICAL CORD PLASMA FROM A PREGNANT WOMEN THAT WANTS TO SAVE THE UMBILICAL CORD CELLS. THIS BOTTLE WAS NEGATIVE IN THE INSTRUMENT, HOWEVER THE SENSOR LOOKED STRANGE SO THE CUSTOMER SUBCULTURE THE BOTTLE AND RECEIVED A POSITIVE RESULT FOR ACTINOMYCES EUROPAEUS. THERE WAS NO IMPACT AND NO TREATMENT WAS ADMINISTERED TO THE PATIENT OR BABY. IT'S ONLY TO BE RECORDED THAT IN THAT SAMPLE SOMETHING WAS DETECTED. THE BOTTOM OF THIS BOTTLE SHOWS THAT THE SENSOR TURNS BLUE INSTEAD OF YELLOW, WHICH IS WHY THE CUSTOMER KNEW THEY NEEDED TO SUBCULTURE. THERE NO ADDITIVE ADDED TO THE BOTTLE ONLY CORD STEM CELL BLOOD. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7489922 ↗
• DeathSep 27, 2017False Negative Result; False Negative Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH THE BACT/ALERT® UNIT. THE CUSTOMER REPORTED AN INITIAL BOTTLE ((B)(4)) WAS LOADED ON (B)(6) 2013 AND THE INSTRUMENT FLAGGED THE BOTTLE AS A NEGATIVE RESULT AFTER FIVE (5) DAYS ON (B)(6) 2013. AN ANALYSIS OF THE DATA INDICATES THIS BOTTLE WAS UNLOADED AS POSITIVE AT APPROXIMATELY 9 HRS., BUT RELOADED TO CONTINUE TESTING THROUGH THE FIVE (5) DAY PROTOCOL. A SECOND BOTTLE ((B)(4)) WAS LOADED ON (B)(6) 2013 AND THE INSTRUMENT FLAGGED THE BOTTLE AS POSITIVE AT 9.36 HOURS ON (B)(6) 2013. THE ORGANISM THAT GREW WAS IDENTIFIED AS KLEBSIELLA PNEUMONIAE. THE PATIENT IS A (B)(6) YEAR OLD FEMALE. THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. ON THE EVENING OF (B)(6) 2013, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT BECAUSE THE CAP HAD COME OFF OF HER PICC LINE, AND WAS NON-SYMPTOMATIC. A BLOOD DRAW WAS PERFORMED ON THE PATIENT AND SENT TO THE LABORATORY FOR TESTING. THE PATIENT HAD A PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE FOR ADMINISTRATION OF NOURISHMENT. THE PATIENT DIED ON (B)(6) 2013. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: Death

  MAUDE report 6898368 ↗
• MalfunctionMar 31, 2017No Device Output; Device Inoperable; No Device Output; Device Inoperable

  A CUSTOMER IN THE (B)(6) REPORTED TO BIOMÉRIEUX A PRODUCT PROBLEM IN ASSOCIATION WITH BACT/ALERT® CONTROL MODULE PKGD 3D. ON (B)(6) 2016 THE STAFF IN THE BACTERIAL SCREENING LAB IN (B)(6) NOTICED THAT THE CONTROLLER UNIT ON SYSTEM C HAD GONE BLANK, ALTHOUGH THE INCUBATORS COULD STILL BE HEARD AGITATING. ON (B)(6) THE CUSTOMER IDENTIFIED THAT THERE WERE DATA GAPS IN THE RECORDS. THIS EXPOSED A RISK THAT THE INITIAL NEGATIVE RESULT OBSERVED IN THE DATA MANAGER ON (B)(6) WAS NOT A REAL NEGATIVE RESULT - AND THUS THERE WAS A LOWER CONFIDENCE IN THE BACTERIAL STATUS OF ALL THE PLATELETS THAT WERE UNDER TEST IN THIS SYSTEM. THE CUSTOMER REPORTED THE INCIDENT TO THE MEDICINES & HEALTHCARE PRODUCTS REGULATORY AGENCY MHRA THROUGH SABRE - SERIOUS ADVERSE BLOOD REACTIONS AND EVENTS (ON LINE REPORTING SYSTEM). THE FILE NUMBER IS SABRE REF. 2016/012/030/HV1/002. 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 HAS BEEN INITIATED AND A 3D BACKUP HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6450094 ↗

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-0773-2007 · Aug 14, 2006 · Terminated
  BacT/ALERT Classic System Software, Blood Culturing System
• Z-0776-2007 · Aug 14, 2006 · Terminated
  BacT/ALERT 3D 60 Systems Software, Blood Culturing System
• 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-0612-05 · May 27, 2005 · Terminated
  Bac T/ALERT 3D Control Module
• Z-0456-05 · Sep 17, 2004 · Terminated
  BacT/ALERT(BTA) Classic instruments.