Recall Z-0786-2023— Biomerieux Inc

Name: FDA recall Z-0786-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-09

Class II · Ongoing

Class II FDA medical device recall by Biomerieux Inc, initiated 2022-11-09. FDA's recall record names no specific 510(k) clearance for this event. Product: API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500. Reason: As the temperature and time out of range was exceeded, product performances cannot be guaranteed.

Recalling firm: Biomerieux Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-11-09
Firm location: Hazelwood, MO, United States

Product description

API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Data sourced from openFDA. This site is unofficial and independent of the FDA.