Recall Z-1408-2021— Biomerieux Inc

Name: FDA recall Z-1408-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-16

Class II · Terminated

Class II FDA medical device recall by Biomerieux Inc, initiated 2021-03-16, terminated 2024-08-06. It names one FDA 510(k) clearance: K933549. Product: VIDAS¿ CMV IgM 30 Tests. Reason: bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01)..

Recalling firm: Biomerieux Inc
Classification: Class II
Status: Terminated
Initiated: 2021-03-16
Terminated: 2024-08-06
Firm location: Hazelwood, MO, 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

Reason for recall

bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).

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