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Terminated

Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.

FDA Recall Z-1147-03 · Posted 2003-08-21

Recalling FirmZeus Scientific Inc
Recall StatusTerminated
Product CodeMID
Date Initiated2001-06-22
Date Terminated2003-08-20
Product Quantity130

Reason for Recall

Bacterial contamination of the high positive control.

Firm Action

Recall letter were sent via DHL to consignee on 6/22/2001 which instructed to return or discard any remaining inventory.

Root Cause

Other

Distribution Pattern

All product was shipped to St. Louis, MO

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984173THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEMZeus Scientific, Inc. · 1998-12-22

Official Source

View FDA Recall →

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

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