Z-0762-2021 Class II Terminated
FDA device recall Z-0762-2021 was initiated by Becton Dickinson & Co. on December 8, 2020 and is designated Class II. Reason for recall: BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction … The recall status is terminated (terminated October 3, 2023). Affected quantity: 34825 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- January 6, 2021
- Initiation Date
- December 8, 2020
- Termination Date
- October 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34825 eaches
Product Description
BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448608
Reason for Recall
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection
Distribution Pattern
Nationwide
Code Information
All unexpired lots UDI: 00382904486082