Class 2 Device Recall BD BACTEC" MGIT" 960 PZA Kit

• Date Initiated by Firm: July 18, 2024
• Date Posted: August 16, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2686-2024
• Recall Event ID: 95023
• 510(K)Number: K021582
• Product Classification: Susceptibility test powders, antimycobacterial - Product Code MJA
• Product: BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
• Code Information: 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
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• For Additional Information Contact: SAME; 304-839-4504
• Manufacturer Reason for Recall: May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
• FDA Determined Cause: Under Investigation by firm
• Action: ***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 awareness. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements. 1. BD will issue credit to the customers as applicable. 2. BD has identified the root cause and is taking action to prevent recurrence of this product issue. North American Regional Complaint Center Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Complaints when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com Recall related questions: BDRC12@bd.com
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MJA