Recall Z-0825-2023— Biomerieux Inc

Name: FDA recall Z-0825-2023
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. It names one FDA 510(k) clearance: K960989. Product: ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373. 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

510(k) clearances named in this recall

1 on FDA's record

K960989 — ETEST SUBMISSION FOR IMIPENEMAb Biodisk·cleared 1996-05-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373

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.