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Terminated

Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.

FDA Recall Z-1095-03 · Posted 2003-08-12

Recalling FirmZeus Scientific Inc
Recall StatusTerminated
Product CodeLFZ
Date Initiated2003-06-12
Date Terminated2006-02-22
Product Quantity270 kits

Reason for Recall

The Calibrator included within the kit may be losing reactivity.

Firm Action

All customers were notified via recall letter on June 12, 2003. Letter sent out via Airborne Express. All product is to be returned to Zeus or destroyed.

Root Cause

Other

Distribution Pattern

The product was distributed to 6 distributors and 24 direct accounts in the United States and Internationally. Canada; Sweden; Costa Rica; Czech; Indonesia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K891081CMV ELISA TEST SYSTEMZeus Scientific, Inc. · 1989-06-02

Official Source

View FDA Recall →

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

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