Z-0837-2023 Class II Ongoing
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
- 15 units
Product Description
VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
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 03573026399023, Batch Numbers: 6702239503