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Terminated

Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G.

FDA Recall Z-1127-03 · Posted 2003-08-12

Recalling FirmMeridian Bioscience Inc
Recall StatusTerminated
Product CodeLFZ
Date Initiated2003-06-18
Date Terminated2004-03-29
Product Quantity43 kits

Reason for Recall

The Low Positive Standard kit component is losing potency that may result in false positive test results.

Firm Action

The firm notified their customers by telephone and fax on 6/18/2003.

Root Cause

Other

Distribution Pattern

The kits were shipped to end-users located in CA, UT, NY, MD, KY; and to a foreign distributor in Belgium.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K924096CMV ELISA TEST SYSTEMZeus Scientific, Inc. · 1993-04-02

Official Source

View FDA Recall →

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

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