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
- Company
- Diasorin Inc.
- Recall Initiated
- January 23, 2004
- Posted
- March 18, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0632-05
- Quantity
- 16 kits
- Firm Location
- Stillwater, MN
Reason for Recall
DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.
Distribution
GA, NY & KS
Lot / Code Info
catalog # 7800, lot # 039229, expiration date 12/23/04
Root Cause
Other
Action Taken
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.
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