Reported Aug 28, 2024 · Ongoing

BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from…

Becton Dickinson & Co.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Becton Dickinson & Co. · 7 Loveton Cir · Sparks, MD · 21152-9212

Is this the product you have?

  • BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture
  • to pyrazinamide (PZA) Catalog Number245128
Lot codes and dates
  • UDI-DI(01) 0038290245128
  • Lot NumbersAmended
    • 8/1/24
    • 3104416
    • 3156654
    • 3191569
    • 3233971
    • 3241654
    • 3248314
    • 3269157
    • 3298311
    • 3298317
    • 3304389
    • 3324422
    • 3338965
    • 4002353
    • 4009894
    • 4036330
    • 4051247
Amount recalled
12,383 eaches

Where it was sold

  • Nationwide

Why it was recalled

May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.