BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes 245122 (UDI 00382902451228)Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00382902451228), received between Jul 12, 2021 and Aug 13, 2026 — classified as 82 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (73 reports).

2 other recalls cover devices cleared under the same FDA submission (K974883); 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 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240107 ↗
• MalfunctionMay 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, AN UNSPECIFIED NUMBER OF ATYPICAL PATIENT RESULTS WERE OBTAINED FROM A MGIT320 INSTRUMENT. IT WAS NOTED THE CUSTOMER RECEIVED "UNEXPLAINED GROWTH UNITS IN MGIT TUBES" AND NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257663 ↗
• MalfunctionMay 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, AN UNSPECIFIED NUMBER OF ATYPICAL PATIENT RESULTS WERE OBTAINED FROM A MGIT320 INSTRUMENT. IT WAS NOTED THE CUSTOMER RECEIVED "UNEXPLAINED GROWTH UNITS IN MGIT TUBES" AND NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257644 ↗
• MalfunctionApr 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE NEGATIVE PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. CONFIRMATORY TESTING WAS NOTED TO HAVE BEEN PERFORMED AND THE ERRONEOUS FALSE NEGATIVE RESULT WAS NOT REPORTED TO THE CLINICIAN. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941053 ↗
• MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, AN UNSPECIFIED NUMBER OF FALSE NEGATIVE PATIENT RESULTS WERE OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER ALSO DID NOT PROVIDE A BATCH NUMBER, BUT NOTED THIS ISSUE HAS OCCURRED WITH RANDOM BATCH NUMBERS. THE AFFECTED PATIENT SAMPLES ARE OBSERVED TO HAVE BACILLUS GROWTH AND ARE CONFIRMED POSITIVE FOR BACILLI BY BACILLOSCOPY. NO ERRONEOUS FALSE NEGATIVE RESULTS WERE RELEASED TO THE CLINICIAN. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911580 ↗
• MalfunctionApr 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE NEGATIVE PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE ERRONEOUS RESULT WAS OBVIOUS TO THE CUSTOMER SINCE THERE WAS GROWTH ON SOLID MEDIA AND THE SAMPLE WAS FROM A KNOWN PATIENT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817160 ↗
• MalfunctionApr 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE NEGATIVE PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE ERRONEOUS RESULT WAS OBVIOUS TO THE CUSTOMER SINCE THERE WAS GROWTH ON SOLID MEDIA AND THE SAMPLE WAS FROM A KNOWN PATIENT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815092 ↗
• MalfunctionApr 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE NEGATIVE PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE ERRONEOUS RESULT WAS OBVIOUS TO THE CUSTOMER SINCE THERE WAS GROWTH ON SOLID MEDIA AND THE SAMPLE WAS FROM A KNOWN PATIENT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815091 ↗
• MalfunctionApr 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) NEGATIVE PATIENT RESULT WAS OBTAINED FROM A MGIT 960 INSTRUMENT. UPON PERFORMING PARALLEL TESTING WHICH INCLUDED CULTURING USING LOWENSTEIN¿JENSEN MEDIA AND TB-ICT, A POSITIVE RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801203 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 31 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700790 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 38 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700789 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 37 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700788 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 35 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700786 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 56 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700649 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 58 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700647 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 60 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700646 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 61 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700645 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 59 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700644 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 57 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700643 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 55 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700641 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 53 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700640 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 54 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700639 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 44 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700637 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 43 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700634 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. THE CUSTOMER IS UNABLE TO PROVIDE THE NUMBER OF AFFECTED PATIENT SAMPLES OR TUBES USED WITH A SPECIFIC PRODUCT LOT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 52 OF 61.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700631 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K974883. One submission often covers many models, so check the product and lot details in each record.

• Z-0028-2014 · Sep 9, 2013 · Terminated
  BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube suppl
• Z-2890-2011 · Mar 28, 2011 · Terminated
  BD BACTEC(tm) MGI (tm) System Software, Catalog 445922, Lot V5.02A. Product Usage: The BACTEC(tm) MGIT (tm) System Software is used in the MGIT 960 and MGIT 320 instruments for