Recall Z-0833-2023— Biomerieux Inc

Name: FDA recall Z-0833-2023
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: K040845. Product: VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400. 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

K040845 — VITEK 2 ESBL TESTbioMerieux, Inc.·cleared 2004-06-08

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

VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400

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.