Z-2686-2024Class II

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

Name: Z-2686-2024 BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium...
Creator: Becton Dickinson & Co.
Published: 2024-07-18
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2024-07-18 / 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) Catalog... on 2024-07-18. FDA classified it as Class II and gives the reason as "May intermittently produce falsely resistant results for pyrazinamide (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-2686-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-18
Posted: 2024-08-16
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) Catalog Number: 245128
Product code: MJA Susceptibility Test Powders, Antimycobacterial
Reason for recall: May intermittently produce falsely resistant results for pyrazinamide (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. ***UPDATE 8/1/24*** BD issued an Urgent Medical Device Correction Update letter on 8/1/24 as lots were inadvertently missed on the communication sent on 18Jul2024. BD issued URGENT: Medical Device Correction letter on 18Jul2024 via email and mail . Letter states reason for recall, health risk and action to take: 1. Customeers should discard the affected product immediately. 2. There are no recommendations for retesting or reviewing previous patient test results. Actions to be taken by customer: 1. Immediately inspect your inventory for the specific catalog and lot number listed above. Destroy affected product subject to the recall following your institution s process of destruction. 2. Ensure the contents of this notification are read and understood. 3. Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the product to ensure
Quantity in commerce: 12,383 eaches
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brunei, Brazil, Canada, China, Costa Rica, Dominican Republic, Guatemala, Guyana, Hong Kong, Haiti, Indonesia, India, Japan, Korea, Myanmar, Macau, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, El Salvador, Thailand, Trinidad and Tobago, Taiwan, Vietnam.
Product codes and lots: UDI-DI: (01) 0038290245128 Lot Numbers: Amended 8/1/24 3104416 3156654 3191569 3233971 3241654 3248314 3269157 3298311 3298317 3304389 3324422 3338965 4002353 4009894 4036330 4051247

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2686-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2686-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-16

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)