BD BACTEC™ MGIT™ 960 PZA Medium 245115Recalls & reported problems
Becton, Dickinson And Company · BD BACTEC™ MGIT™ 960 PZA Medium, 25 tests · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD BACTEC MGIT 960 PZA medium, a lab test that checks which tuberculosis drugs will work, has 108 reports, with no deaths and no injuries. Most reports describe incorrect results, mainly tests wrongly showing that bacteria resist pyrazinamide, and a few describe contamination or false positive results. Reports fell from 68 in the prior 12 months to 6 in the latest 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
- 102
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 30382902451151), received between Jul 28, 2022 and Sep 10, 2025 — classified as 102 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (94 reports).
2 other recalls cover devices cleared under the same FDA submission (K021582); 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 Readings94
- Contamination5
- False Positive Result2
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions102
Recent adverse event reports
The 25 most recent of 102 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA KIT, THERE WERE AN UNSPECIFIED NUMBER OF FALSE RESISTANT RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23014327 ↗MalfunctionSep 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22961004 ↗MalfunctionSep 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960997 ↗MalfunctionSep 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960996 ↗MalfunctionSep 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960988 ↗MalfunctionSep 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WERE AN UNKNOWN NUMBER OF FALSE RESISTANT PZA RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22953161 ↗MalfunctionSep 3, 2025Contamination; Contamination
IT WAS REPORTED WHILE USING THE BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC), AN UNKNOWN NUMBER OF BOTTLES WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22952969 ↗MalfunctionSep 3, 2025Contamination; Contamination
IT WAS REPORTED WHILE USING THE BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC), AN UNKNOWN NUMBER OF BOTTLES WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22952968 ↗MalfunctionSep 3, 2025Contamination; Contamination
IT WAS REPORTED WHILE USING THE BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC), AN UNKNOWN NUMBER OF BOTTLES WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22952965 ↗MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WERE AN UNKNOWN NUMBER OF FALSE RESISTANT RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22948638 ↗MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA KIT, THERE WERE AN UNSPECIFIED NUMBER OF FALSE RESISTANT RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22933642 ↗MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT TO PYRAZINAMIDE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22933601 ↗MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT TO PYRAZINAMIDE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22933521 ↗MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT TO PYRAZINAMIDE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22933506 ↗MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22930016 ↗MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22930012 ↗MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22930011 ↗MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22929974 ↗MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22929958 ↗MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22929877 ↗MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22929876 ↗MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22929873 ↗MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22929864 ↗MalfunctionJul 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22587064 ↗MalfunctionJul 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA MEDIUM, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22586509 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K021582. One submission often covers many models, so check the product and lot details in each record.
- Z-2023-2025 · May 20, 2025 · Open, ClassifiedBD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
- Z-2686-2024 · Jul 18, 2024 · Open, ClassifiedBD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
Other SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL devices
- BD BACTEC™ MGIT™ 960 PZA Kit 245128Becton, Dickinson And Company · SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL580 reports
- BD BACTEC™ MGIT™ 960 SIRE Kit 245123Becton, Dickinson And Company · SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL166 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.
How reports and recalls are matched · Editorial policy · Report an error on this page