Z-0784-2023 Class II Ongoing
FDA device recall Z-0784-2023 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 20 E 25 STRIPS, CATALOG 20100
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 03573026047818, Batch Number 1009226560