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Terminated

Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.

FDA Recall Z-1031-03 · Posted 2003-07-19

Recalling FirmZeus Scientific Inc
Recall StatusTerminated
Product CodeDHR
Date Initiated2001-11-09
Date Terminated2006-10-03
Product Quantity505

Reason for Recall

Calibrator C not meeting its optical density specification.

Firm Action

Customers were notified of the recall via DHL on 11/9/2001. Customers were instructed to return or destroy product.

Root Cause

Other

Distribution Pattern

The Sigma product was shipped to Sigma directly. The Zeus product was shipped to customers nationwide via DHL. Zeus customers consists of hospitals, and clinical laboratories.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961277RF IGM ELISA TEST SYSTEMZeus Scientific, Inc. · 1996-05-08

Official Source

View FDA Recall →

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

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