BD BACTEC™ MGIT™ 320 Instrument 441743Recalls & reported problems
Becton, Dickinson And Company · BD BACTEC™ MGIT™ 320 Instrument · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD BACTEC MGIT 320 instrument is a laboratory system used to grow and detect bacteria in blood cultures. The 56 reports mostly describe growth results that came back wrong — false positives or false negatives — plus a few leaks or splash incidents. No deaths and no injuries are described, and reports say no patients were affected. 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
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00382904417437), received between Mar 31, 2021 and Aug 7, 2026 — classified as 56 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (25 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 Result25
- False Negative Result14
- Incorrect, Inadequate or Imprecise Result or Readings14
- Leak/Splash2
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions56
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026False Negative Result
It was reported while using BD BACTEC¿ MGIT¿ 320 Instrument, there was an unknown number of false negative results. There was no health impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50179339 ↗MalfunctionJun 17, 2026False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 320 INSTRUMENT, THERE WAS ONE (1) FALSE NEGATIVE RESULT. THE SAMPLE WAS FROM A PATIENT UNDERGOING TREATMENT FOR M. AVIUM. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25534547 ↗MalfunctionMay 27, 2026False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 320 INSTRUMENT, THERE WERE FALSE NEGATIVE RESULTS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301426 ↗MalfunctionMay 1, 2026False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 320 INSTRUMENT, THERE WERE FALSE POSITIVE RESULTS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056538 ↗MalfunctionFeb 12, 2026False Positive Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 320 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 24322442 ↗MalfunctionJan 7, 2026False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 320 INSTRUMENT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23990300 ↗MalfunctionDec 17, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 320 INSTRUMENT, THERE WERE FALSE NEGATIVE RESULTS. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828901 ↗MalfunctionOct 17, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 320 INSTRUMENT, THERE WERE FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23325448 ↗MalfunctionOct 15, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 320 INSTRUMENT, THERE WERE FALSE NEGATIVE RESULTS. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301093 ↗MalfunctionSep 8, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 320 INSTRUMENT, THERE WERE FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22994280 ↗MalfunctionSep 2, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 320 INSTRUMENT, THERE WERE MULTIPLE FALSE RESISTANT RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22946527 ↗MalfunctionJul 15, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 320 INSTRUMENT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22508002 ↗MalfunctionApr 4, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 320 INSTRUMENT, THERE WAS A FALSE NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21773875 ↗MalfunctionJan 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC MGIT 320 INSTRUMENT, THERE WERE AN UNSPECIFIED NUMBER OF FALSE POSITIVE OCCURRENCES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057600 ↗MalfunctionDec 13, 2024False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC MGIT 320 INSTRUMENT, AN UNSPECIFIED NUMBER OF FALSE POSITIVES WAS RECEIVED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20925894 ↗MalfunctionNov 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 1 OF 2 IT WAS REPORTED THAT WHILE USING BD BACTEC MGIT 320 INSTRUMENT, THERE WAS FALSE RESISTANCE SEEN IN THE RESULTS OF ONE (1) SAMPLE. THE RESULT WAS SHOWN AS COMPLETE AND WITH RESISTANCE TO SOME DRUGS, BUT THE SAMPLE TRACE DID NOT SHOW ANY CURVE GROWTH IN ANY OF THE TUBES ANALYZED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20734919 ↗MalfunctionNov 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 2. IT WAS REPORTED THAT WHILE USING BD BACTEC MGIT 320 INSTRUMENTS, THERE WAS FALSE RESISTANCE SEEN IN THE RESULTS OF ONE (1) SAMPLE. THE RESULT WAS SHOWN AS COMPLETE AND WITH RESISTANCE TO SOME DRUGS, BUT THE SAMPLE TRACE DID NOT SHOW ANY CURVE GROWTH IN ANY OF THE TUBES ANALYZED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20734747 ↗MalfunctionOct 7, 2024False Negative Result; False Negative Result
IT WAS REPORTED THAT WHILE USING BD BACTEC MGIT 320 INSTRUMENT, TWO (2) TUBES RESULTED AS FALSE NEGATIVE. THE TUBES WERE REMOVED FROM THE INSTRUMENT FOR GRAM STAIN AND SUBCULTURE AND NO GROWTH WAS DETECTED. AFTER RE-INCUBATION AND SUBSEQUENT GRAM STAIN AND SUBCULTURE, GROWTH WAS DETECTED. NO PATIENT RESULTS WERE AFFECTED AS THE FINAL RESULTS WERE REPORTED AS POSITIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20390966 ↗MalfunctionJun 5, 2024False Positive Result; False Positive Result
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 320 SYSTEM, A FALSE POSITIVE RESULT WAS RECEIVED. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19473810 ↗MalfunctionMay 23, 2024False Positive Result; False Positive Result
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 320 SYSTEM, THERE WERE SIXTEEN (16) FALSE POSITIVES. CUSTOMER PERFORMED CONFIRMATORY TESTING AND NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19388096 ↗MalfunctionApr 25, 2024False Negative Result; False Negative Result
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 320 SYSTEM A FALSE NEGATIVE RESULT WAS FOUND. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19181913 ↗MalfunctionJan 4, 2024False Negative Result; False Negative Result
IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 320 SYSTEM, THERE WERE FALSE NEGATIVE SAMPLES. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18446398 ↗MalfunctionJan 1, 2024False Positive Result; False Positive Result
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 320 SYSTEM, THERE WERE AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18423184 ↗MalfunctionDec 12, 2023False Positive Result; False Positive Result
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 320 SYSTEM, FALSE POSITIVE RESULT WAS OBTAINED. THIS IS A REPORT OF ONE OCCURRENCE, NO REPORT OF ADVERSE OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18315613 ↗MalfunctionOct 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 320 SYSTEM THAT THERE WERE FALSE POSITIVES FOR MBT AS A RESULT OF POSSIBLE CONTAMINATION. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS THAT THEY HAVE DETECTED SEVERAL INCIDENTS WITH VIALS TURNING POSITIVE IN LESS THAN 48HRS INCUBATION AND FLAGGING POSITIVE WITH A GU=0. CUSTOMER REPORT SOME OF THE VIALS GIVE A POSITIVE FOR OTHER BACTERIAL GROWTH BUT NO FOR MTB."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17968353 ↗
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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