VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
FDA Recall #Z-0789-2023 — Class II — November 9, 2022
Product Description
VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
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
14 units
Distribution
US Nationwide distribution.
Code Information
UDI/DI 03573026131937, Batch Numbers: 2432261103
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated