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Terminated

DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom.

FDA Recall Z-0927-05 · Posted 2005-06-25

Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeMID
Date Initiated2004-11-01
Date Terminated2006-07-22
Product Quantity49

Reason for Recall

DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL).

Firm Action

Customers were notifed of the product and the problem and were advised to destroy any remaining inventory and replacements were offered.

Root Cause

Other

Distribution Pattern

NY, KS, GA & MT

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001981DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500Axis-Shield , Ltd. · 2000-08-21

Official Source

View FDA Recall →

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

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