Z-0815-2023 Class II Ongoing

Recalled by Biomerieux Inc — Hazelwood, MO

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
46 units

Product Description

VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071

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 03573026362836, Batch Numbers: 1009391190, 1009434380, 1009472100