BACT/ALERT® 3D RIGHT COMBINATION MODULE 200290Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03573026047566), received between Mar 23, 2017 and May 7, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2021False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® 3D INSTRUMENT WHEN PERFORMING AN EXTERNAL QUALITY CONTROL ASSESSMENT. THE CUSTOMER STATED THEIR BACT/ALERT® 3D INSTRUMENT DID NOT DETECT GROWTH WHEN TESTING THE EXTERNAL QUALITY CONTROL STRAINS. THE CUSTOMER ALSO STATED THE INSTRUMENT HAS BEEN IN USE SINCE 2005 BUT HAS NOT PERFORMED REGULAR MAINTENANCE ON THE INSTRUMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED REGARDING THE FALSE NEGATIVE RESULTS OBTAINED BY THE BACT/ALERT® 3D INSTRUMENT. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL SURVEY, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11793789 ↗
• MalfunctionDec 27, 2019False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT IN ASSOCIATION WITH THE BACT/ALERT® FA PLUS CULTURE BOTTLE AND THE BACT/ALERT® 3D INSTRUMENT (REF. 200290, SERIAL #: 601CR5641). THE CUSTOMER LOADED TWO BOTTLES FROM ONE PATIENT ON 22NOV2019. THE FIRST BOTTLE HAD A POSITIVE RESULT ON 25NOV2019, AND THE SECOND BOTTLE INCUBATED FOR FIVE (5) DAYS WITH A NEGATIVE RESULT. BOTH BOTTLES ARE FROM THE SAME LOT (REF#: 410851, LOT#: 4052663). THE BLOOD CULTURE FROM THE FIRST BOTTLE WITH THE POSITIVE RESULT WAS SUBCULTURED ON COS, EMB, PVX (RTA BRAND), AND THE GROWTH SHOWED THAT IT WAS A CANDIDA SPECIES. THE BOTTLE ISOLATE WAS THEN TESTED ON VITEK® 2 COMPACT WITH THE VITEK 2 YST CARD, AND THE RESULT SHOWED THAT IT WAS CANDIDA CIFERII. THE SECOND BOTTLE WITH THE NEGATIVE RESULT WAS INOCULATED ONTO RTA CHROMOGENIC CANDIDA AGAR AND SHOWED GROWTH DETERMINED TO BE OF THE CANDIDA SPECIES. THE GROWN MICROORGANISM WAS ALSO TESTED ON THE VITEK 2 YST CARD AND IDENTIFIED AS C. CIFERII. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT HARMED OR TREATED INCORRECTLY DUE TO THE DISCREPANT RESULT. THE PATIENT HAD TWO BOTTLES, ONE WHICH FLAGGED AS TRUE POSITIVE, AND THE ERROR WAS NOTICED BY THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9527524 ↗
• MalfunctionNov 22, 2019Smoking; Smoking

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF SMOKE BEING FROM EMITTED THEIR BACT/ALERT® 3D INSTRUMENT. THE CUSTOMER STATED SMOKE WAS OBSERVED COMING FROM THE UPPER PART OF THE BACT/ALERT® 3D INSTRUMENT NEAR THE CONTROL PANEL. AFTER THE INSTRUMENT WAS DISCONNECTED AND TAKEN OUT OF SERVICE, A REPLACEMENT BACT/ALERT® 3D INSTRUMENT WAS INSTALLED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE SMOKING INSTRUMENT LED TO ANY ADVERSE EVENT RELATED TO USER OR PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9365872 ↗
• MalfunctionSep 5, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT® 3D INSTRUMENT. THE CUSTOMER REPORTED THAT WHEN THE BOTTLES FLAGGED POSITIVE BY THE INSTRUMENT THE LABORATORY PERFORMED A SUBCULTURE USING BOLD MACCONKEY, CHOCOLATE AGAR INCUBATING THE PLATES +/- CO2 AT 37°C FOR 48 H. THE CUSTOMER REPORTED THAT THE CONCERNED BOTTLES WERE UNLOADED AND INCUBATED FURTHER IN THE EXTERNAL INCUBATOR TOGETHER WITH THE SUBCULTURES. IF THERE WAS NO GROWTH ON THE SUBCULTURE AFTER 48 HOURS, THE LABORATORY INOCULATED ANOTHER SAMPLE FROM THE BOTTLE AND INCUBATED IT AGAIN FOR 48 HOURS. THIS STEP HAS BEEN REPEATED UNTIL THE END OF THE INCUBATION TIME DEFINED FOR THE BOTTLES (SEVEN DAYS). PATIENT RESULTS: DELAY IN REPORTING RESULTS TO THE PHYSICIAN. THE DELAY IS CONSIDERED FROM THE FIRST RESULT RELEASE AND TO THE FINAL RESULT. THE CUSTOMER REPORTED FALSE POSITIVE DIRECTLY AFTER THE BOTTLES HAVE BEEN FLAGGED POSITIVE IN BACT/ALERT AND CORRECTED THE RESULT AT THE END OF THE INCUBATION TIME, AFTER PERFORMING SUBCULTURES. THE FIRST RESULT RELEASED WAS POSITIVE AND TOOK ALMOST SIX (6) DAYS TO RELEASE THE FINAL RESULT AS NEGATIVE. THE BACT/ALERT RESULTS HAVE BEEN RELEASED TO TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7845491 ↗
• MalfunctionSep 5, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT® 3D INSTRUMENT. THE CUSTOMER REPORTED THAT WHEN THE BOTTLES FLAGGED POSITIVE BY THE INSTRUMENT THE LABORATORY PERFORMED A SUBCULTURE USING BOLD MACCONKEY, CHOCOLATE AGAR INCUBATING THE PLATES +/- CO2 AT 37°C FOR 48 H. THE CUSTOMER REPORTED THAT THE CONCERNED BOTTLES WERE UNLOADED AND INCUBATED FURTHER IN THE EXTERNAL INCUBATOR TOGETHER WITH THE SUBCULTURES. IF THERE WAS NO GROWTH ON THE SUBCULTURE AFTER 48 HOURS, THE LABORATORY INOCULATED ANOTHER SAMPLE FROM THE BOTTLE AND INCUBATED IT AGAIN FOR 48 HOURS. THIS STEP HAS BEEN REPEATED UNTIL THE END OF THE INCUBATION TIME DEFINED FOR THE BOTTLES (SEVEN DAYS). PATIENT RESULTS: FALSE POSITIVE RESULT. DELAY IN REPORTING OF RESULTS. THE BACT/ALERT RESULTS HAVE BEEN RELEASED TO THE PHYSICIAN, WHEN THE BOTTLES WERE FLAGGED POSITIVE. AFTER HAVING THE SUBCULTURE RESULTS, THE CUSTOMER INFORMED THE PHYSICIAN ABOUT THE FALSE POSITIVE RESULTS. THERE IS NO EVIDENCE REGARDING INAPPROPRIATE PATIENT TREATMENT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7845482 ↗
• MalfunctionSep 5, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6)NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT® 3D INSTRUMENT. THE CUSTOMER REPORTED THAT WHEN THE BOTTLES FLAGGED POSITIVE BY THE INSTRUMENT THE LABORATORY PERFORMED A SUBCULTURE USING BOLD MACCONKEY, CHOCOLATE AGAR INCUBATING THE PLATES +/- CO2 AT 37°C FOR 48 H. THE CUSTOMER REPORTED THAT THE CONCERNED BOTTLES WERE UNLOADED AND INCUBATED FURTHER IN THE EXTERNAL INCUBATOR TOGETHER WITH THE SUBCULTURES. IF THERE WAS NO GROWTH ON THE SUBCULTURE AFTER 48 HOURS, THE LABORATORY INOCULATED ANOTHER SAMPLE FROM THE BOTTLE AND INCUBATED IT AGAIN FOR 48 HOURS. THIS STEP HAS BEEN REPEATED UNTIL THE END OF THE INCUBATION TIME DEFINED FOR THE BOTTLES (SEVEN DAYS). PATIENT RESULTS: GRAPH LOOKS LIKE A REAL POSITIVE RESULT AND THE CUSTOMER REPORTED THAT THE RESULT WAS FLAGGED BY ACCELERATION. THE POSITIVITY INDEX IS 22/2. THE PATIENT HAD THE LEUCOCYTES SLOWLY HIGHER 15850/ML. IT IS NOT A REASON FOR THE POSITIVITY. THE BACT/ALERT RESULTS HAVE BEEN RELEASED TO THE PHYSICIAN, WHEN THE BOTTLES WERE FLAGGED POSITIVE. AFTER HAVING THE SUBCULTURE RESULTS, THE CUSTOMER INFORMED THE PHYSICIAN ABOUT THE FALSE POSITIVE RESULTS. THERE IS NO EVIDENCE REGARDING INA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7845481 ↗
• MalfunctionSep 5, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT® 3D INSTRUMENT. THE CUSTOMER REPORTED THAT WHEN THE BOTTLES FLAGGED POSITIVE BY THE INSTRUMENT THE LABORATORY PERFORMED A SUBCULTURE USING BOLD MACCONKEY, CHOCOLATE AGAR INCUBATING THE PLATES +/- CO2 AT 37°C FOR 48 H. THE CUSTOMER REPORTED THAT THE CONCERNED BOTTLES WERE UNLOADED AND INCUBATED FURTHER IN THE EXTERNAL INCUBATOR TOGETHER WITH THE SUBCULTURES. IF THERE WAS NO GROWTH ON THE SUBCULTURE AFTER 48 HOURS, THE LABORATORY INOCULATED ANOTHER SAMPLE FROM THE BOTTLE AND INCUBATED IT AGAIN FOR 48 HOURS. THIS STEP HAS BEEN REPEATED UNTIL THE END OF THE INCUBATION TIME DEFINED FOR THE BOTTLES (SEVEN DAYS). PATIENT RESULTS: FALSE POSITIVE RESULT. DELAY IN REPORTING OF RESULTS. THE BACT/ALERT RESULTS HAVE BEEN RELEASED TO THE PHYSICIAN, WHEN THE BOTTLES WERE FLAGGED POSITIVE. AFTER HAVING THE SUBCULTURE RESULTS, THE CUSTOMER INFORMED THE PHYSICIAN ABOUT THE FALSE POSITIVE RESULTS. THERE IS NO EVIDENCE REGARDING INAPPROPRIATE PATIENT TREATMENT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7845480 ↗
• MalfunctionMar 23, 2017Off-Label Use

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A BACT/ALERT® 3D INSTRUMENT (UDI# (B)(4)) THAT WAS PROCESSING BOTTLES UTILIZING AN INCORRECT BOTTLE TYPE, GENERIC INSTEAD OF FAN PLUS. THE BOTTLE TYPE IS BEING SENT FROM THE CUSTOMER'S LIS, WHICH IS NOT A BIOMÉRIEUX PRODUCT. A REVIEW OF THE INSTRUMENT BACK-UP WAS PERFORMED BY GCS. DURING THIS REVIEW, IT WAS NOTED THAT THE BOTTLE WAS BEING SCANNED INTO THE SYSTEM BY THE USER AND WAS REGISTERING AS THE PROPER BOTTLE TYPE. THEN THE LIS WAS TRANSMITTING THE INFORMATION AND THE BOTTLE TYPE WAS BEING OVERWRITTEN WITH THE GENERIC BOTTLE TYPE. THE CUSTOMER WAS INFORMED THAT FOR 17 BOTTLES WITH NEGATIVE RESULTS PER THE ANALYSIS, RE-CALCULATIONS WERE DONE AND THOSE BOTTLES HAD A POSITIVE STATUS. AGAIN, THE CUSTOMER REPORTED NOTICING SOME BOTTLES NOT HAVING CORRECT TYPES AND INDICATED THEY MANUALLY CORRECTED THEM. THE CUSTOMER REPORTED COMING ACROSS SOME FALSE NEGATIVE BOTTLES AND FALSE POSITIVE BOTTLES, BUT THEY WERE ALWAYS MONITORING THEIR GRAPHS AND GRAM STAINING THE SUSPICIOUS BOTTLES. IF THE RESULT WAS FALSE, THEY WERE RE-INCUBATING THE BOTTLE IN THE INSTRUMENT. THE CUSTOMER ALSO STATED THERE WERE NO COMPLAINTS FROM PHYSICIANS REGARDING INACCUR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6428099 ↗

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.