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BD BACTEC™ MGIT™ 960 SIRE Kit

BECTON, DICKINSON AND COMPANY · Model 245123 · UDI-DI 00382902451235

MJA Prescription

510(k) clearances

931

Adverse events

Recalls

Facilities

Description

BD BACTEC™ MGIT™ 960 SIRE Kit, carton of 4 lyophilized drug vials, and 8 SIRE Supplements

Recalls

Date	Firm	Reason
2025-05-20	Becton Dickinson & Co.	BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
2024-07-18	Becton Dickinson & Co.	May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
2010-08-31	Becton Dickinson & Co.	In vitro diagnostic device components are mislabeled.
2010-08-31	Becton Dickinson & Co.	In vitro diagnostic device components are mislabeled.
2010-08-31	Becton Dickinson & Co.	In vitro diagnostic device components are mislabeled.
2010-08-31	Becton Dickinson & Co.	In vitro diagnostic device components are mislabeled.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.