—#209120

Product

BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128

FDA product code: MJA — Susceptibility Test Powders, Antimycobacterial
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K021582
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

***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

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-07-18
Posted by FDA: 2024-08-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209120. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.