BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure recall
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA)…
Why was BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure recalled?
May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA)…
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 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.
- Recall date
- August 28, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)