BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from cu

FDA device recall Z-2686-2024 · posted 2024-08-16 · Open, Classified

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.

Action taken

***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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MJA

Quantity affected

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, Hait

Date initiated

2024-07-18

Date posted

2024-08-16

Location

Sparks, MD

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