PlainRecalls
FDA Devices Moderate Class II Ongoing

ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788

Reported: January 11, 2023 Initiated: November 9, 2022 #Z-0860-2023

Product Description

ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788

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
2 units
Distribution
US Nationwide distribution.
Location
Hazelwood, MO

Frequently Asked Questions

What product was recalled?
ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788. Recalled by Biomerieux Inc. Units affected: 2 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-0860-2023.