BD BACTEC™ MGIT™ 960 PZA Kit 245128Recalls & reported problems
Becton, Dickinson And Company · BD BACTEC™ MGIT™ 960 PZA Kit · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD BACTEC MGIT PZA test kit, used to check tuberculosis samples for drug resistance, has 532 adverse event reports, with no deaths and 4 injuries. Almost all describe incorrect results, mainly samples reported as resistant to pyrazinamide when they were not. Reports fell from 414 in the prior 12 months to 10 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
- 580
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 580 adverse event reports that list this exact device (DI 00382902451280), received between May 17, 2021 and Sep 3, 2026 — classified as 4 injuries, 576 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (578 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 Readings578
- False Positive Result1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions580
Recent adverse event reports
The 25 most recent of 580 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588369 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588368 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588367 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588365 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588364 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588362 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588360 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588358 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588356 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588354 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588343 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588341 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588340 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588339 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588337 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588161 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588160 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588159 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588158 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588157 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588156 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588155 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588154 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588153 ↗MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported while using the BD BACTEC¿ MGIT¿ 960 PZA Kit, one (1) false resistant patient sample to PZA was obtained. Whole Genome Sequencing was performed and showed the absence of a PZA resistance mutation. There were no health impact or consequences reported.This is report 10 of 37.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588152 ↗
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 SIRE Kit 245123Becton, Dickinson And Company · SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL166 reports
- BD BACTEC™ MGIT™ 960 PZA Medium 245115Becton, Dickinson And Company · SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL102 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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