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Terminated

Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B

FDA Recall Z-1065-03 · Posted 2003-07-30

Recalling FirmZeus Scientific Inc
Recall StatusTerminated
Product CodeLFX
Date Initiated2000-02-24
Date Terminated2004-10-25
Product Quantity205

Reason for Recall

The high positive control/low positive standard ratio recovering too low.

Firm Action

Recall letters sent out via DHL on 2/24/2000

Root Cause

Other

Distribution Pattern

The two lots were shipped to St. Louis, MO. No subrecall was initiated.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984180THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEMZeus Scientific, Inc. · 1999-07-20

Official Source

View FDA Recall →

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

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