BD BACTEC™ MGIT™ 960 Instrument 445870Recalls & reported problems
Becton, Dickinson And Company · BD BACTEC™ MGIT™ 960 Instrument · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD BACTEC MGIT 960 instrument is a laboratory system used for blood culturing. Its 186 reports include no deaths and 3 injuries. Many describe false positive results, where a sample wrongly reads as positive, and false negative results, where it wrongly reads as negative. 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
- 186
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 00382904458706), received between Apr 15, 2019 and Jun 19, 2026 — classified as 3 injuries, 183 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (71 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
- False Positive Result71
- False Negative Result50
- Incorrect, Inadequate or Imprecise Result or Readings40
- Leak/Splash12
- Break5
- Fluid/Blood Leak5
- Fire4
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions182
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 186 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2026False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE FALSE POSITIVE RESULTS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25564287 ↗MalfunctionJun 19, 2026False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE FALSE POSITIVE RESULTS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 2 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25564285 ↗MalfunctionJun 19, 2026False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE FALSE POSITIVE RESULTS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25560765 ↗MalfunctionMay 21, 2026False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 INSTRUMENT, A FALSE NEGATIVE RESULT WAS OBTAINED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25240965 ↗MalfunctionMay 21, 2026False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 INSTRUMENT, A FALSE NEGATIVE RESULT WAS OBTAINED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25240958 ↗MalfunctionMay 7, 2026False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 INSTRUMENT, AN UNSPECIFIED NUMBER OF NEGATIVE RESULTS WERE OBTAINED. AFTER ZN STAINING WAS PERFORMED AND A POSITIVE RESULT WAS OBTAINED, THE RESULTS WERE DETERMINED TO BE FALSE NEGATIVE RESULTS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25112696 ↗MalfunctionApr 7, 2026False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE AN UNSPECIFIED NUMBER OF FALSE NEGATIVE RESULTS. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24800623 ↗MalfunctionFeb 12, 2026False Negative Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WAS A FALSE NEGATIVE RESULT. THERE WAS NO REPORT OF ADVERSE IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322285 ↗MalfunctionFeb 9, 2026False Positive Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE FALSE NEGATIVE RESULTS. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292995 ↗MalfunctionJan 30, 2026False Negative Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE FALSE NEGATIVE RESULTS. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24221400 ↗MalfunctionJan 5, 2026False Positive Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE FALSE POSITIVE PATIENT RESULTS. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23959661 ↗MalfunctionDec 23, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE FALSE NEGATIVE RESULTS. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878779 ↗MalfunctionDec 17, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828594 ↗MalfunctionDec 17, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE FALSE NEGATIVE RESULTS. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828131 ↗MalfunctionNov 25, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645645 ↗MalfunctionNov 25, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645460 ↗MalfunctionNov 25, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645459 ↗MalfunctionNov 25, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645430 ↗MalfunctionNov 24, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE FALSE NEGATIVE RESULTS. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23632261 ↗MalfunctionNov 19, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 INSTRUMENTS, THERE WERE FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23596424 ↗MalfunctionSep 8, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE FALSE POSITIVE RESULTS. THERE WAS NO ADVERSE IMPACT TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22994324 ↗MalfunctionAug 7, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 INSTRUMENT FALSE POSITIVE RESULTS OCCURRED. THE USER ALSO NOTED THAT THE DRAWER SLIDES WERE ALSO FAULTY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22739687 ↗MalfunctionAug 1, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 INSTRUMENT THE USER NOTED BACTERIA GROWING AT THE BOTTOM OF THE MGIT TUBE THAT WAS REPORTED TO BE NEGATIVE AT THE END OF THE 6-WEEK PROTOCOL. THE USER WAS INFORMED THAT THIS FAILURE CAN BE ASSOCIATED WITH THE PATIENT'S MEDICATIONS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22690110 ↗MalfunctionJul 29, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 INSTRUMENT, THERE WERE AN UNKNOWN NUMBER OF FALSE NEGATIVE RESULTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22644489 ↗MalfunctionJul 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SYSTEM, INCORRECT AST RESULTS WERE GIVEN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22531092 ↗
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
- 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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