Z-0843-2023 Class II Ongoing
FDA device recall Z-0843-2023 was initiated by Biomerieux Inc on November 9, 2022 and is designated Class II. Reason for recall: As the temperature and time out of range was exceeded, product performances cannot be guaranteed The recall status is ongoing. Affected quantity: 218 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 11, 2023
- Initiation Date
- November 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 218 units
Product Description
VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670
Reason for Recall
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Distribution Pattern
US Nationwide distribution.
Code Information
UDI/DI 03573026437183, Batch Numbers: 2752252403