DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwestern Avenue, Stillwater, MN 55082-0285
FDA Recall Z-0632-05 · Posted 2005-03-18
Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeMID
Date Initiated2004-01-23
Date Terminated2006-07-22
Product Quantity16 kits
Reason for Recall
DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.
Firm Action
Customers were notified via a letter which described the product and the problem. Recommended to destroy all affected kits and stated that the kits will be replaced.
Root Cause
Other
Distribution Pattern
GA, NY & KS
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.