PlainRecalls
FDA Devices Moderate Class II Ongoing

VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071

Reported: January 11, 2023 Initiated: November 9, 2022 #Z-0815-2023

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

Details

Recalling Firm
Biomerieux Inc
Units Affected
46 units
Distribution
US Nationwide distribution.
Location
Hazelwood, MO

Frequently Asked Questions

What product was recalled?
VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071. Recalled by Biomerieux Inc. Units affected: 46 units.
Why was this product recalled?
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Which agency issued this recall?
This recall was issued by the FDA Devices on January 11, 2023. Severity: Moderate. Recall number: Z-0815-2023.