BACT/ALERT® MP BACT/ALERT MPRecalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 03573026596163), received between Dec 5, 2019 and Feb 19, 2024 — classified as 87 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (82 reports).

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 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2024False Negative Result; False Negative Result

  INTENDED USE: THE BACT/ALERT® MP REAGENT SYSTEM CONSISTS OF THE BACT/ALERT® MP CULTURE BOTTLE WITH A REMOVABLE CLOSURE USED IN CONJUNCTION WITH THE BACT/ALERT® MP ANTIMICROBIAL SUPPLEMENT AND THE BACT/ALERT® MP NUTRIENT SUPPLEMENT. THE BACT/ALERT® MP REAGENT SYSTEM IS DESIGNED FOR USE WITH BACT/ALERT® 3D MYCOBACTERIA DETECTION SYSTEMS FOR RECOVERY AND DETECTION OF MYCOBACTERIA FROM STERILE BODY SPECIMENS OTHER THAN BLOOD, AND FROM DIGESTED/DECONTAMINATED CLINICAL SPECIMENS. ISSUE DESCRIPTION: A CUSTOMER IN IRELAND NOTIFIED BIOMÉRIEUX OF AN INSTRUMENT FALSE NEGATIVE RESULT IN ASSOCIATION WITH BACT/ALERT MP 100 BTLS (REF. 419744, BATCH NUMBER 0001060658, EXPIRATION DATE 15-AUG-2024) FOR ONE PATIENT ON THE BACT/ALERT 3D INSTRUMENT FOR A MYCOBACTERIUM POSITIVE SAMPLE. THE CUSTOMER REPORTED THAT "THE CLINICAL SAMPLE WAS IDENTIFIED ON SOLID CULTURE LJ PYRUVATE & LJ GLYCEROL MEDIAL AT 33 DAYS. AS PER THEIR PROCEDURE THEY RETAIN AN ALIQUOT OF PROCESSED SAMPLE AND THIS WAS INCUBATED USING A NEW LIQUID CULTURE BOTTLE OF A DIFFERENT LOT NUMBER AND THE SAMPLE FLAGGED POSITIVE AT 23 DAYS." ACCORDING TO BIOMÉRIEUX GLOBAL CUSTOMER SERVICE, IN THIS CASE THERE WAS A FALSE NEGATIVE RESULT (DUE TO IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730954 ↗
• MalfunctionMar 3, 2023False Negative Result; False Negative Result

  INTENDED USE: THE BACT/ALERT® MP REAGENT SYSTEM CONSISTS OF THE BACT/ALERT® MP CULTURE BOTTLE WITH A REMOVABLE CLOSURE USED IN CONJUNCTION WITH THE BACT/ALERT® MP ANTIMICROBIAL SUPPLEMENT AND THE BACT/ALERT® MP NUTRIENT SUPPLEMENT. THE BACT/ALERT® MP REAGENT SYSTEM IS DESIGNED FOR USE WITH BACT/ALERT® 3D MYCOBACTERIA DETECTION SYSTEMS FOR RECOVERY AND DETECTION OF MYCOBACTERIA FROM STERILE BODY SPECIMENS OTHER THAN BLOOD, AND FROM DIGESTED/DECONTAMINATED CLINICAL SPECIMENS. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT FOR AN AFB (ACID-FAST BACTERIA) SAMPLE ASSOCIATED WITH BACT/ALERT MP CULTURE BOTTLE - REF. 419744, LOT 0001059238. THE CUSTOMER INDICATED THAT AFTER SIX (6) WEEKS OF INCUBATION AND A FINAL RESULT OF "NEGATIVE", THE CUSTOMER NOTED A GRAINY GROWTH. DUE TO THE PRESENCE OF GRAINY GROWTH AND THE PATIENT'S HISTORY OF A MYCOBACTERIUM ABSCESS, KINYOUN STAINING WAS PERFORMED. THE CUSTOMER NOTED THAT A KINYOUN STAIN CONFIRMED THE PRESENCE OF A NON-TUBERCULOID MYCOBACTERIA. THE CUSTOMER ALSO NOTED THAT THE SAMPLE HAS BEEN SUBMITTED TO AN EXTERNAL LAB FOR FURTHER IDENTIFICATION. MYCOBACTERIUM AVIUM INTRACELLULARE COMPLEX WAS ID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16480858 ↗
• MalfunctionMar 30, 2022False Negative Result; False Negative Result

  INTENDED USE: THE BACT/ALERT® MP REAGENT SYSTEM CONSISTS OF THE BACT/ALERT® MP CULTURE BOTTLE WITH A REMOVABLE CLOSURE USED IN CONJUNCTION WITH THE BACT/ALERT® MP ANTIMICROBIAL SUPPLEMENT AND THE BACT/ALERT® MP NUTRIENT SUPPLEMENT. THE BACT/ALERT® MP REAGENT SYSTEM IS DESIGNED FOR USE WITH BACT/ALERT® 3D MYCOBACTERIA DETECTION SYSTEMS FOR RECOVERY AND DETECTION OF MYCOBACTERIA FROM STERILE BODY SPECIMENS OTHER THAN BLOOD, AND FROM DIGESTED/DECONTAMINATED CLINICAL SPECIMENS. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE NEGATIVE RESULT IN ASSOCIATION WITH THE BACT/ALERT® MP CULTURE BOTTLE (REF. 419744) WHEN TESTING NEQAS SURVEY SPECIMEN 6675. THE IMPACTED LOT NUMBER WAS NOT SPECIFIED. THE CUSTOMER STATED THE BACT/ALERT® MP CULTURE BOTTLE FAILED TO DETECT PRESENCE OF MYCOBACTERIUM TUBERCULOSIS IN SAMPLE 6675. THE CUSTOMER PERFORMED TERMINAL MICROSCOPY AND DID NOT FIND PRESENCE OF ACID FAST BACILLI. THE CUSTOMER THEN REPEATED TESTING OF SPECIMEN 6675 WITH THE BACT/ALERT® MP CULTURE BOTTLE; FALSE NEGATIVE RESULT WAS OBTAINED. BIOMÉRIEUX CUSTOMER SERVICE REVIEWED THE SURVEY FOR THE UK NEQAS FOR MYCOBACTERIUM CULTURE DISTRIBUTION. THE REVIEW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13956156 ↗
• MalfunctionNov 7, 2021False Negative Result; False Negative Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF OBTAINING A FALSE NEGATIVE RESULT IN ASSOCIATION WITH THE BACT/ALERT® MP CULTURE BOTTLE (REF. (B)(4), LOT 0001057060) WHEN TESTING A CAP SURVEY STRAIN. THE CUSTOMER STATED THE BOTTLE WAS INOCULATED WITH 0.5ML OF SAMPLE AND INCUBATED ON THE BACT/ALERT INSTRUMENT FOR 4-5 WEEKS. THE CUSTOMER STATED TURBIDITY WAS NOTICED INSIDE THE BOTTLE; HOWEVER, THE BOTTLE ITSELF REMAINED NEGATIVE. BOTH BOTTLES WERE SUB-CULTURED AND WERE POSITIVE FOR GROWTH. BIOMERIEUX CUSTOMER SERVICE HAS REQUESTED THE IDENTIFICATION OF THE SUB-CULTURED BOTTLES AND THE CUSTOMER¿S BACKUP DATA. AS THERE IS NO PATIENT ASSOCIATED WITH THIS CAP STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMERIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760901 ↗
• MalfunctionNov 7, 2021False Negative Result; False Negative Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF OBTAINING A FALSE NEGATIVE RESULT IN ASSOCIATION WITH THE BACT/ALERT® MP CULTURE BOTTLE (REF. 419744, LOT 0001057060) WHEN TESTING A PATIENT SAMPLE. THE CUSTOMER STATED THE BOTTLE WAS INOCULATED WITH 0.5ML OF PATIENT SAMPLE AND INCUBATED ON THE BACT/ALERT INSTRUMENT FOR 4-5 WEEKS. THE CUSTOMER STATED TURBIDITY WAS OBSERVED INSIDE THE BOTTLE; HOWEVER, THE BOTTLE RESULT REMAINED NEGATIVE. THE BOTTLE WAS SUB-CULTURED AND WAS POSITIVE FOR GROWTH. BIOMERIEUX CUSTOMER SERVICE HAS REQUESTED THE IDENTIFICATION OF THE SUB-CULTURED BOTTLE AND THE CUSTOMER¿S BACKUP DATA. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE NEGATIVE RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMERIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759379 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF 419744, LOT 1053174). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE. SIX (6) OF THE BOTTLES WERE EITHER CONTAMINATED OR ACTUALLY POSITIVE WHILE 11 WERE FALSE POSITIVE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434498 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF 419744, LOT 1053174). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE. SIX (6) OF THE BOTTLES WERE EITHER CONTAMINATED OR ACTUALLY POSITIVE WHILE 11 WERE FALSE POSITIVE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434497 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF 419744, LOT 1053174). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE. SIX (6) OF THE BOTTLES WERE EITHER CONTAMINATED OR ACTUALLY POSITIVE WHILE 11 WERE FALSE POSITIVE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434491 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF 419744, LOT 1053174). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE. SIX (6) OF THE BOTTLES WERE EITHER CONTAMINATED OR ACTUALLY POSITIVE WHILE 11 WERE FALSE POSITIVE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434489 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF 419744, LOT 1053174). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE. SIX (6) OF THE BOTTLES WERE EITHER CONTAMINATED OR ACTUALLY POSITIVE WHILE 11 WERE FALSE POSITIVE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434487 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF 419744, LOT 1053174). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE. SIX (6) OF THE BOTTLES WERE EITHER CONTAMINATED OR ACTUALLY POSITIVE WHILE 11 WERE FALSE POSITIVE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434485 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF 419744, LOT 1053174). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE. SIX (6) OF THE BOTTLES WERE EITHER CONTAMINATED OR ACTUALLY POSITIVE WHILE 11 WERE FALSE POSITIVE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434477 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF 419744, LOT 1053174). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE. SIX (6) OF THE BOTTLES WERE EITHER CONTAMINATED OR ACTUALLY POSITIVE WHILE 11 WERE FALSE POSITIVE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434473 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF 419744, LOT 1053174). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE. SIX (6) OF THE BOTTLES WERE EITHER CONTAMINATED OR ACTUALLY POSITIVE WHILE 11 WERE FALSE POSITIVE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434471 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF 419744, LOT 1053174). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE. SIX (6) OF THE BOTTLES WERE EITHER CONTAMINATED OR ACTUALLY POSITIVE WHILE 11 WERE FALSE POSITIVE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434469 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF 419744, LOT 1053174). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE. SIX (6) OF THE BOTTLES WERE EITHER CONTAMINATED OR ACTUALLY POSITIVE WHILE 11 WERE FALSE POSITIVE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434467 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF. 419744, LOT 1053687). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE; THE BOTTLES WERE SUBCULTURED, AND ELEVEN (11) WERE CONFIRMED TO BE FALSE POSITIVE. THE CUSTOMER CONFIRMED THERE WAS NO ADVERSE PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434464 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF. 419744, LOT 1053687). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE; THE BOTTLES WERE SUBCULTURED, AND ELEVEN (11) WERE CONFIRMED TO BE FALSE POSITIVE. THE CUSTOMER CONFIRMED THERE WAS NO ADVERSE PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434461 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF. 419744, LOT 1053687). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE; THE BOTTLES WERE SUBCULTURED, AND ELEVEN (11) WERE CONFIRMED TO BE FALSE POSITIVE. THE CUSTOMER CONFIRMED THERE WAS NO ADVERSE PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434453 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF. 419744, LOT 1053687). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE; THE BOTTLES WERE SUBCULTURED, AND ELEVEN (11) WERE CONFIRMED TO BE FALSE POSITIVE. THE CUSTOMER CONFIRMED THERE WAS NO ADVERSE PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434449 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF. 419744, LOT 1053687). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE; THE BOTTLES WERE SUBCULTURED, AND ELEVEN WERE CONFIRMED TO BE FALSE POSITIVE. THE CUSTOMER CONFIRMED THERE WAS NO ADVERSE PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434424 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF. 419744, LOT 1053687). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE; THE BOTTLES WERE SUBCULTURED, AND ELEVEN WERE CONFIRMED TO BE FALSE POSITIVE. THE CUSTOMER CONFIRMED THERE WAS NO ADVERSE PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434323 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF. 419744, LOT 1053687). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE; THE BOTTLES WERE SUBCULTURED, AND ELEVEN WERE CONFIRMED TO BE FALSE POSITIVE. THE CUSTOMER CONFIRMED THERE WAS NO ADVERSE PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434319 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF. 419744, LOT 1053687). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE; THE BOTTLES WERE SUBCULTURED, AND ELEVEN (11) WERE CONFIRMED TO BE FALSE POSITIVE. THE CUSTOMER CONFIRMED THERE WAS NO ADVERSE PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434306 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT® MP (REF. 419744, LOT 1053687). THE CUSTOMER STATED THAT AFTER A RECENT PREVENTIVE MAINTENANCE WAS PERFORMED, 17 BOTTLES WERE FLAGGED AS POSITIVE; THE BOTTLES WERE SUBCULTURED, AND ELEVEN WERE CONFIRMED TO BE FALSE POSITIVE. THE CUSTOMER CONFIRMED THERE WAS NO ADVERSE PATIENT IMPACT DUE TO THE FALSE POSITIVE RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434303 ↗