BD BBL™ MGIT™ Mycobacteria Growth Indicator Tubes 245113Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ MGIT™ Mycobacteria Growth Indicator Tubes, 4 mL, carton of 100 tubes · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 30382902451137), received between Aug 17, 2021 and Aug 29, 2025 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (9 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings9
- False Positive Result3
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP), THERE WAS FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22923694 ↗MalfunctionAug 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP), THERE WAS FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22923691 ↗MalfunctionAug 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP), THERE WAS FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22923673 ↗MalfunctionAug 29, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP), THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22922585 ↗MalfunctionAug 29, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP), THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22922573 ↗MalfunctionAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 1 OF 5. IT WAS REPORTED WHEN USING THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, CONTAMINATION OCCURRED WITH M. TUBERCULOSIS COMPLEX IN ONE (1) PATIENT SAMPLE PER IDENTIFICATION FROM QUEST. NO INFORMATION COULD BE PROVIDED BY THE CUSTOMER REGARDING PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19955467 ↗MalfunctionAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 5 OF 5 IT WAS REPORTED WHEN USING THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, CONTAMINATION OCCURRED WITH M. TUBERCULOSIS COMPLEX IN ONE (1) PATIENT SAMPLE PER IDENTIFICATION FROM QUEST. NO INFORMATION COULD BE PROVIDED BY THE CUSTOMER REGARDING PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19955412 ↗MalfunctionAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 3 OF 5. IT WAS REPORTED WHEN USING THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, CONTAMINATION OCCURRED WITH M. TUBERCULOSIS COMPLEX IN ONE (1) PATIENT SAMPLE PER IDENTIFICATION FROM QUEST. NO INFORMATION COULD BE PROVIDED BY THE CUSTOMER REGARDING PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19955403 ↗MalfunctionAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 4 OF 5. IT WAS REPORTED WHEN USING THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, CONTAMINATION OCCURRED WITH M. TUBERCULOSIS COMPLEX IN ONE (1) PATIENT SAMPLE PER IDENTIFICATION FROM QUEST. NO INFORMATION COULD BE PROVIDED BY THE CUSTOMER REGARDING PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19955256 ↗MalfunctionAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 5. IT WAS REPORTED WHEN USING THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, CONTAMINATION OCCURRED WITH M. TUBERCULOSIS COMPLEX IN ONE (1) PATIENT SAMPLE PER IDENTIFICATION FROM QUEST. NO INFORMATION COULD BE PROVIDED BY THE CUSTOMER REGARDING PATIENT IMP
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19955098 ↗MalfunctionNov 16, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP) HAD BIOLOGICAL CONTAMINATION WHICH LED TO FALSE RESULTS. THIS OCCURRED 4 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18147880 ↗MalfunctionNov 2, 2023False Positive Result; False Positive Result
IT WAS REPORTED THAT WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP), THERE WERE 3 FALSE POSITIVE RESULTS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A COMPLAINT ABOUT SUSPECTED FALSE POSITIVE EVENTS IN THREE CASES. THE CUSTOMER CULTURED ACID-FAST BACILLI BY THE MANUAL METHOD. IN THREE CASES, THE BACTERIA REACTED WITH UV LIGHT ,HOWEVER IT COULD NOT BE CONFIRMED ON THE SMEAR. BD HAVE RECEIVED A PHONE CALL FROM A CLIENT TO CONFIRM WHETHER THERE HAVE BEEN ANY OTHER SIMILAR EVENTS.:
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18060634 ↗MalfunctionAug 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP) FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A SUBCULTURE WAS USED TO CONFIRM THE RESULTS AS FALSE NEGATIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "WE HAVE MGIT CUSTOMER THAT HAD AN INCIDENT OF FN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12334512 ↗
Other SYSTEM, BLOOD CULTURING devices
- BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes 245122Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING1,472 reports
- BD BACTEC™ Plus Aerobic/F Culture Vials 442023Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING2 deaths1,063 reports
- BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials 442021Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING1 death791 reports
- BD BACTEC™ FX Top 441385Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING2 recalls1 death475 reports
- BD BACTEC™ Peds Plus™/F Culture Vials 442020Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING355 reports
- BD BACTEC™ Plus Anaerobic/F Culture Vials 442022Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING237 reports
- BD BACTEC™ MGIT™ 960 Instrument 445870Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING186 reports
- BACT/ALERT® FA PLUSBiomerieux , Inc. · System, blood culturing1 recall126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page