BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes 245122 (UDI 30382902451229)Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ MGIT™ Mycobacteria Growth Indicator Tubes, 7 mL, carton of 100 tubes · Class 1
All models of BD BACTEC MGIT Mycobacteria Growth Indicator Tubes (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
These BD BACTEC MGIT Mycobacteria Growth Indicator Tubes are blood culture tubes used to grow mycobacteria from samples. The 1,472 reports most often describe inaccurate or unclear results, with some describing false positive and false negative results and mold contamination. The reports list no deaths and no injuries. Reports in the last 12 months number 1, compared with 1,228 in the 12 months before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,472
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,472 adverse event reports that list this exact device (DI 30382902451229), received between Jan 19, 2021 and Jan 15, 2026 — classified as 1,472 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1,159 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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1,159
- False Positive Result129
- Device Markings/Labelling Problem67
- False Negative Result63
- Contamination28
- Missing Information12
- Contamination of Device Ingredient or Reagent8
- Leak/Splash8
Patient problems
- No Clinical Signs, Symptoms or Conditions1,470
- No Consequences Or Impact To Patient6
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 1,472 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, A FALSE POSITIVE RESULT WAS FLAGGED ON A MGIT INSTRUMENT FOR ONE (1) PATIENT SAMPLE TUBE. THE CUSTOMER CONFIRMED NO GROWTH WAS PRESENT IN THE TUBE. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24085432 ↗MalfunctionOct 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE FALSE NEGATIVE RESULT WAS OBTAINED; THE IMMUNOCHROMATOGRAPHIC AND BACILLOSCOPIC TEST CONFIRMED POSITIVE RESULT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23293336 ↗MalfunctionSep 18, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED BEFORE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THE CUSTOMER OBSERVED THE OUTSIDE LABEL OF ONE (1) REPACKAGED CARTON KIT CONTAINED AN EXPIRATION DATE ISSUE. INCLUDED IN THE REPACKAGED CARTON KIT WERE SUPPLEMENT KITS (EXPIRATION DATE 03-OCT-2025) ALONG WITH MGIT MYCOBACTERIA GROWTH INDICATOR TUBES (EXPIRATION DATE 31-AUG-2025). THE OUTSIDE LABEL OF THE REPACKAGED CARTON KIT INDICATED THE EXPIRATION DATE WAS 03-OCT-2025 AND NOT THE EARLIER DATE OF 31-AUG-2025. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084473 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977618 ↗MalfunctionSep 5, 2025Contamination; Contamination
IT WAS REPORTED WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML, A TUBE WAS CONTAMINATED WITH MOLD. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977601 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977599 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977598 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977596 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977594 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977588 ↗MalfunctionSep 5, 2025Contamination; Contamination
IT WAS REPORTED WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML, A TUBE WAS CONTAMINATED WITH MOLD. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977586 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977585 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977584 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977583 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977582 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977580 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977579 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977578 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977577 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977576 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977575 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977573 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977572 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977571 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977569 ↗
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 · TerminatedBBL (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 · TerminatedBD 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
Other SYSTEM, BLOOD CULTURING devices
- 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
- BACT/ALERT® PF PLUSBiomerieux , Inc. · System, blood culturing1 recall124 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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