BD BACTEC MGIT Mycobacteria Growth Indicator TubesRecalls & reported problems across all models
Becton, Dickinson And Company · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,554
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of BD BACTEC MGIT Mycobacteria Growth Indicator Tubes by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 1,554 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2021 and Aug 13, 2026 — classified as 1,554 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1,232 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BD BACTEC MGIT Mycobacteria Growth Indicator Tubes problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1,232
- False Positive Result129
- Device Markings/Labelling Problem68
- False Negative Result64
- Contamination28
- Missing Information12
- Contamination of Device Ingredient or Reagent8
- Leak/Splash8
Patient problems
- No Clinical Signs, Symptoms or Conditions1,552
- No Consequences Or Impact To Patient6
- No Patient Involvement2
BD BACTEC MGIT Mycobacteria Growth Indicator Tubes models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes 245122SYSTEM, BLOOD CULTURING1,472 reports
- BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes 245122System, blood culturing82 reports
Recent BD BACTEC MGIT Mycobacteria Growth Indicator Tubes adverse event reports
The 15 most recent reports across all models, 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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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