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Terminated

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

FDA Recall Z-0742-2022 · Posted 2022-03-14

Recalling FirmbioMerieux, Inc.
Recall StatusTerminated
Product CodeLKQ
Date Initiated2022-02-09
Date Terminated2026-04-01
Product Quantity480 kits

Reason for Recall

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

Firm Action

The recalling firm issued letters dated 2/9/2022 via Fed Ex Express Priority Overnight delivery service to their U.S. consignees. The letter described the issue, the impact to the user, and the required actions. Those actions included instructing the consignee to stop using and destroy any stock of the recalled lot and to complete the Acknowledgement Form and return it via email or FAX. The quantity discarded was to be completed on the Acknowledgement Form.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, and WV. There was government distribution but no military or foreign distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K933549VIDAS CMV IGM ASSAYBiomerieux Vitek, Inc. · 1994-08-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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