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BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for… recallZ-2023-2025 · Becton Dickinson & Co. · initiated May 20, 2025

Class II Open, Classified All recalls posted in June 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

***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].

Recall details

Recall number
Z-2023-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
May 20, 2025
Posted by the FDA
Jun 25, 2025
Recalling firm
Becton Dickinson & Co.
Quantity
12,256 eaches
Product code
MJA
FDA submissions
K021582
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 description

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

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

2 devices cleared under K021582 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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