Recall Z-0742-2022— bioMerieux, Inc.

Name: FDA recall Z-0742-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-09

Class II · Terminated

Class II FDA medical device recall by bioMerieux, Inc., initiated 2022-02-09, terminated 2026-04-01. It names one FDA 510(k) clearance: K933549. Product: VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.. Reason: Invalid calibrations (out of range high) while using the product..

Recalling firm: bioMerieux, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-02-09
Terminated: 2026-04-01
Firm location: Durham, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K933549 — VIDAS CMV IGM ASSAYBiomerieux Vitek, Inc.·cleared 1994-08-02

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

VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.

Reason for recall

Invalid calibrations (out of range high) while using the product.

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