VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341
FDA Recall #Z-0787-2023 — Class II — November 9, 2022
Product Description
VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341
Reason for Recall
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Recalling Firm
Biomerieux Inc — Hazelwood, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
348 units
Distribution
US Nationwide distribution.
Code Information
UDI/DI 03573026131913, Batch Numbers: 2412101403, 2412103403, 2412103503, 2412106403
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated