VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072
FDA Recall #Z-0816-2023 — Class II — November 9, 2022
Product Description
VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072
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
29 units
Distribution
US Nationwide distribution.
Code Information
UDI/DI 03573026362843, Batch Numbers: 1009346190
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated