PlainRecalls
FDA Devices Moderate Class II Ongoing

VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425

Reported: January 11, 2023 Initiated: November 9, 2022 #Z-0857-2023

Product Description

VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425

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
50 units
Distribution
US Nationwide distribution.
Location
Hazelwood, MO

Frequently Asked Questions

What product was recalled?
VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425. Recalled by Biomerieux Inc. Units affected: 50 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-0857-2023.