VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982
FDA Recall #Z-0853-2023 — Class II — November 9, 2022
Product Description
VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982
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
84 units
Distribution
US Nationwide distribution.
Code Information
UDI/DI 03573026565923, Batch Numbers: 6852245503
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated