Z-2023-2025Class II

BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium...

Name: Z-2023-2025 BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium...
Creator: Becton Dickinson & Co.
Published: 2025-05-20
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2025-05-20 / Open, Classified

FDA source

Becton Dickinson & Co. began a recall of BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) on 2025-05-20. FDA classified it as Class II and gives the reason as "BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2023-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-20
Posted: 2025-06-25
Recalling firm: Becton Dickinson & Co
Product: BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
Product code: MJA Susceptibility Test Powders, Antimycobacterial
Reason for recall: BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
FDA root cause: Under Investigation by firm
Action: ***UPDATE 11/13/2025*** BD Issued an URGENT: Medical Device Correction letters were sent to customers. BD is pleased to announce that we have resumed production of a modified version of the BD BACTEC MGIT 960 PZA Kit which includes modified inoculation methods and reduced shelf-life. BD has conducted a thorough review of the performance from all supported inoculum sources using the synthetic raw material and the following change has been implemented for the BD BACTEC MGIT 960 PZA Kit. 1. Only inoculum prepared from MGIT tubes 3-5 days post-positivity can be currently supported. 2. Inoculum prepared from MGIT tubes 1-2 days past instrument positivity are currently not supported. 3. Inoculum prepared from solid media are currently not supported. Additionally, the shelf life of the product has been adjusted from 18 months to 13 months to reflect the latest internal supporting data. Clinical users should refer to the updated Instructions for Use (IFU) available at https://www.bd.qarad.eifu.online/hcp. Additional languages will be added as translations are completed. An URGENT: Medical Device Correction notice dated 5/20/25 was sent to consignees via mail. The notification instructs consignees to inspect their inventory for recalled units and destroy them per their institution's process of destruction. The recall notification is to be shared at consignee locations with those who utilize the device and to customers who received distributed product. Consignees are to return a completed Customer Response Form to BD. Consignees with any questions are to email [email protected]. Consignees are to report any complaints by phone to 1-844-823-5433 or by email at [email protected].
Quantity in commerce: 12,256 eaches
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2023-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2023-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-25

Product code MJA

K021582Class IIBactec Mgit 960 Pza KitBecton, Dickinson & CO / cleared 2002-07-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)