BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from c
Summary
The FDA issued a Class II for BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testi by Becton Dickinson & Co.. Reason: May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates..
Details
Source
Device Recall
External ID
Z-2686-2024
Action Date
2024-08-28
Status
Ongoing
Category
device
Product Description
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
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
Quantity Affected: 12,383 eaches
Reason for Recall
May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-18
Company
Sparks, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Becton Dickinson & Co. has 73 FDA actions in our database, including 73 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Becton Dickinson & Co.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton Dickinson & Co. have FDA actions?
Becton Dickinson & Co. has 73 FDA actions in our database, including 73 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2686-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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