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U.S. Department of Health and Human Services

Class 2 Device Recall DiaSorin AntiCardiolipin IgA ELISA kit

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  Class 2 Device Recall DiaSorin AntiCardiolipin IgA ELISA kit see related information
Date Initiated by Firm January 23, 2004
Date Posted March 18, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall Number Z-0632-05
Recall Event ID 30919
510(K)Number K001981  
Product Classification System, Test, Anticardiolipin Immunological - Product Code MID
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
Code Information catalog # 7800, lot # 039229, expiration date 12/23/04
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact DiaSorin Technical Services
800-328-1482
Manufacturer Reason
for Recall		 DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 16 kits
Distribution GA, NY & KS
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MID and Original Applicant = AXIS-SHIELD LTD.
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