BD BACTEC™ MGIT™ 960 Calibration Vial 445871Recalls & reported problems
Becton, Dickinson And Company · BD BACTEC™ MGIT™ 960 Calibration Vial, 17 pack · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382904458713), received between Jan 12, 2024 and Sep 2, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (5 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 Negative Result5
- False Positive Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING CALIBRATOR KIT MGIT 960, THERE WAS A FALSE NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22935153 ↗MalfunctionSep 2, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING CALIBRATOR KIT MGIT 960, THERE WAS A FALSE NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22934480 ↗MalfunctionSep 2, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING CALIBRATOR KIT MGIT 960, THERE WAS A FALSE NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22934385 ↗MalfunctionSep 2, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE USING CALIBRATOR KIT MGIT 960, THERE WAS A FALSE NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22934380 ↗MalfunctionJul 1, 2024False Positive Result; False Positive Result
IT WAS REPORTED AFTER USING THE BD BACTEC MGIT 960 CALIBRATOR KIT, AN UNSPECIFIED NUMBER OF TUBES TESTED FALSE POSITIVE. THE CUSTOMER NOTED NO BACTERIA OR MYCOBACTERIA IN THE FALSE POSITIVE TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19651104 ↗MalfunctionJan 12, 2024False Negative Result; False Negative Result
IT WAS REPORTED WHEN USING THE CALIBRATOR KIT MGIT 960 THAT FIVE (5) FALSE NEGATIVE RESULTS WERE OBTAINED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18501593 ↗
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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