BACT/ALERT® VIRTUO® 411661Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03573026369774), received between Mar 26, 2018 and Dec 23, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 27, 2018Terminated

   The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE) can service the associated cells P24 - P27, where the calibration standards typically reside. If the calibration standards are not returned to the designated locations, an anomaly may occur.

   Z-0229-2019 · Root cause: Software design · Recall details · FDA record ↗

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.

• MalfunctionDec 23, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF EXPERIENCING A DROPPED BOTTLE ERROR IN WHICH THE CULTURE BOTTLE WAS NOT FULLY SEATED IN A CELL AND LED TO A DELAY IN REPORTING RESULTS 24 HOURS, IN ASSOCIATION WITH THEIR VIRTUO® B UNIT REF 411661, SERIAL (B)(4). THE BOTTLE WAS INCUBATED AND AGITATED CORRECTLY BUT THE GROWTH WAS NOT MONITORED BY THE VIRTUO. THE ISSUE WAS IDENTIFIED WHILE THE CUSTOMER WAS ATTEMPTING TO PERFORM CELL CALIBRATIONS. LOCAL CUSTOMER SERVICE (LCS) REVIEWED THE CALIBRATION LOGS AND FOUND THAT THE CALIBRATION FOR CELL L23 HAD FAILED. LCS ASKED THE CUSTOMER TO SEE IF THE CELL WAS EMPTY. THE CUSTOMER FOUND THAT THE BOTTLE WAS IN THE CELL AND WAS APPROXIMATELY 1CM FROM BEING FULLY INSERTED INTO THE CELL. AS RECOMMENDED BY LCS, THE CUSTOMER SUBCULTURED THE BOTTLE THAT WAS FOUND STILL IN THE CELL AND NO GROWTH WAS OBSERVED. NEGATIVE RESULTS WERE ALSO OBTAINED FOR THE PARTNER BOTTLES IN THE VIRTUO. THE CUSTOMER CONFIRMED THAT THERE WAS NO IMPACT TO THE PATIENT TREATMENT DUE TO THE DELAY IN REPORTING RESULTS. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND PERFORMED AN INSPECTION ON THE INSTRUMENT. THE FSE FOUND THAT CELL L23 HAD AN OBSTRUCTION WHICH APPEAR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11066450 ↗
• MalfunctionJun 26, 2020Output Problem; Output Problem

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF AN INSTANCE WHERE AN EMAIL WAS NOT SENT TO NOTIFY THE CUSTOMER OF A POSITIVE BOTTLE IN ASSOCIATION WITH THE CUSTOMER'S VIRTUO® (VRTB-00311), MYLA®, AND LIS. THE CUSTOMER STATED THAT A POSITIVE BOTTLE WAS FLAGGED BY THE VIRTUO® ON (B)(6) 2020 AT 10:41 PM AND WAS NOT UNLOADED BY THE SYSTEM UNTIL THE NEXT DAY AT 09:07 AM. THE CUSTOMER ALSO STATED THAT MYLA® FAILED TO SEND AN ALERT EMAIL FOR THE POSITIVE BOTTLE WHEN THE BOTTLE WAS INITIALLY DETECTED AS POSITIVE. THE CUSTOMER IS A BLOOD BANK CUSTOMER AND CURRENTLY USES THE EMAIL NOTIFICATIONS FOR POSITIVE BOTTLES TO ENSURE THAT THEY CAN STOP THE CORRESPONDING BLOOD BATCH FROM BEING DELIVERED TO PATIENTS. GLOBAL CUSTOMER SERVICE (GCS) REVIEW OF THE CUSTOMER'S "OUT.LOG" FILE CONFIRMED THAT NO EMAIL WAS SENT TO CORRESPOND WITH THE POSITIVE BOTTLE RESULT DETECTED ON (B)(6) 2020 AT 10:41 PM. HOWEVER, FURTHER REVIEW BY GCS IDENTIFIED THAT THE VIRTUO® SENT THE POSITIVE RESULT TO MYLA® AND THEN MYLA® SENT THE POSITIVE RESULT TO THE CUSTOMER'S LIS. THERE WAS NO DELAY OF THE RESULT BEING REPORTED FROM THE VIRTUO® TO THE CUSTOMER'S LIS. THE CUSTOMER CONFIRMED THAT THIS EVENT DID NOT LEAD TO ANY ADVERSE E

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10203152 ↗
• MalfunctionApr 30, 2019Positioning Problem; Positioning Problem

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A BOTTLE PLACEMENT FAILURE IN ASSOCIATION WITH THE VIRTUO®, B UNIT ( REFERENCE 411661 SERIAL (B)(4)). THE MISPLACED BOTTLE HAD FLAGGED POSITIVE, BUT WAS NOT UNLOADED TO THE CHUTE. INSTEAD, THE CUSTOMER REPORTED THAT IT DROPPED INSIDE OF THE INSTRUMENT. THE CUSTOMER CONFIRMED THE BOTTLE FLAGGED POSITIVE ON THE AFTERNOON OF (B)(6) 2019, BUT IT WAS NOT FOUND UNTIL THE FOLLOWING MONDAY MORNING ON (B)(6) 2019. IT SHOULD BE NOTED THAT THE INSTRUMENT WOULD HAVE ALERTED THE CUSTOMER WITH ERROR 7 "BOTTLE DROPPED." NO REPORT WAS MADE BY THE CUSTOMER OF OBTAINING AN ERROR MESSAGE. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM OR DELAYED TREATMENT DUE TO THE DROPPED BOTTLE. THE CUSTOMER REPORTED A DELAY OF GREATER THAN 8 HOURS IN REPORTING RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8566666 ↗
• MalfunctionMar 26, 2018False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT ASSOCIATED WITH BACT/ALERT® VIRTUO INSTRUMENT (REFERENCE 411661). THE CUSTOMER REPORTED THAT THE INSTRUMENT FAILED TO FLAG AN IQMH PROFICIENCY TESTING SAMPLE (BACT-1710-2B CANDIDA PARAPSILOSIS) POSITIVE WITHIN FIVE (5) DAYS. THERE IS NO PATIENT INVOLVEMENT IN THIS EVENT AND NO KNOWN ADVERSE IMPACT TO THE USER. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7369127 ↗