BD BBL™ MGIT™ Mycobacteria Growth Indicator Tubes 245111Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ MGIT™ Mycobacteria Growth Indicator Tubes, 4 mL, carton of 25 tubes · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382902451113), received between May 27, 2020 and Mar 2, 2023 — classified as 1 death, 2 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (1 report).
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- False Negative Result1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- Death1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2023False Negative Result; False Negative Result
IT WAS REPORTED THAT WHILE USING THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (25/SP) THAT THERE WAS FALSE NEGATIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS A POSSIBLE FALSE NEGATIVE INCIDENT WITH TUBES 245111 WITH LOT#: 2272719.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16475809 ↗MalfunctionJun 3, 2020Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (25/SP) REPORTED POSITIVES FOR M. KANSASII FOR 4 PATIENTS. ADDITIONAL SPECIMENS WERE COLLECTED ON 2 DIFFERENT PATIENTS, AND THE SECOND SPECIMENS RESULTED IN NO GROWTH. THE CUSTOMER DID NOT RESPOND TO REQUESTS FOR ADDITIONAL INFORMATION. THEREFORE, IT IS UNKNOWN IF THESE RESULTS WERE ERRONEOUS AND IT IS UNKNOWN IF THEY WERE REPORTED OUT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10114920 ↗DeathMay 27, 2020Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT WHILE USING BD TUBE MGIT 25 EA THEY NOTICED POSSIBLE CONTAMINATION. A PATIENT DEATH WAS REPORTED. NO INFORMATION GIVEN SUGGESTS THAT THE PATIENT DEATH WAS RELATED TO THE DEVICE USED.
Patient problems: Death
MAUDE report 10094180 ↗
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.
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