Z-0810-2023 Class II Ongoing
FDA device recall Z-0810-2023 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: 1 unit.
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
- 1 unit
Product Description
API JAMES 2AMP, CATALOG 70542
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 03573026099893, Batch Numbers: 1009360510