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Terminated

VIDAS CMV IgG Assay

FDA Recall Z-1047-04 · Posted 2004-07-20

Recalling FirmbioMerieux
Recall StatusTerminated
Product CodeLFZ
Date Initiated2004-06-09
Date Terminated2005-01-12
Product Quantity148 units

Reason for Recall

The product may give false positive results.

Firm Action

Consignees were notified by letter on June 9, 2004.

Root Cause

Other

Distribution Pattern

AR, CA, FL, GA, IL, IN, KY, MA, MD, MN, MS, MT, NC, NE, NH, NJ, NY, OH, PA, RI, SD, TN, VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K920661VIDAS CMV IGG ASSAYVitek Systems, Inc. · 1993-02-12

Official Source

View FDA Recall →

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

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