BD BACTEC™ MGIT™ 960 Supplement Kit 245124Recalls & reported problems
Becton, Dickinson And Company · BD BACTEC™ MGIT™ 960 Supplement Kit · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD BACTEC MGIT Supplement Kit is a supplement kit for blood culture testing. All 164 of its adverse event reports are malfunctions, with no injuries and no deaths. Most describe inaccurate lab results, including false positives, and some describe contamination. Reports fell from 48 in the prior 12 months to 0 in the last 12 months. 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
- 164
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 00382902451242), received between Feb 1, 2021 and Sep 5, 2025 — classified as 164 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (83 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 Readings83
- Contamination34
- False Positive Result22
- Contamination of Device Ingredient or Reagent14
- Device Contamination with Chemical or Other Material4
- Device Markings/Labelling Problem3
- Microbial Contamination of Device3
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions164
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 164 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977574 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977570 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977562 ↗MalfunctionSep 3, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22949773 ↗MalfunctionSep 3, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22949772 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22940839 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22940836 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22940829 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22940188 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22940112 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22940100 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22940081 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22940058 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22940050 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22940019 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22939987 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22939981 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22939960 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22939897 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22939856 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22939836 ↗MalfunctionAug 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22895656 ↗MalfunctionAug 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22894439 ↗MalfunctionAug 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22894418 ↗MalfunctionJul 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, FUNGAL PARTICLES WERE OBSERVED IN ONE (1) UNOPENED SUPPLEMENT VIAL. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22636145 ↗
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™ 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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