Diasorin Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
catalog # 7800, lot # 039229, expiration date 12/23/04
Products Sold
catalog # 7800, lot # 039229, expiration date 12/23/04
Diasorin Inc. is recalling DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies due to DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, KS, NY
Page updated: Jan 10, 2026