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Recall Observatory FDA recall evidence

Device product

BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).

Z-2023-2025

May 20, 2025

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 96910
Status
Ongoing
Classification
Class II
Quantity
12,256 eaches
Official record key
device-enforcement:Z-2023-2025

Official wording

Reason: BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.

Code information: Catalog No. 245128; UDI-DI: (01) 0038290245128; Lot No. 4150998, 4177908, 4178500, 4262031, 4262036, 4262037, 4262039, 4262040, 4262044, 4284438, 4284441, 4284443, 4284445, 4284449, 4304789, 4304796, 4347228, 4347230, 4352110, 4362418, 5007456, 5020153, 5050670, 5050671, 5050672, 5050675, 5050678.

Distribution pattern: Worldwide distribution - US Nationwide and the countries of AR, AU, BD, BE, BN, BR, CA, CN, CR, DO, GT, HK, HT, ID, IN, JP, KH, KR, MO, MX, MY, NP, NZ, PE, PH, PK, SG, SV, TH, TW, VN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.