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U.S. Department of Health and Human Services

Class 3 Device Recall DiaSorin AntiCardiolipin IgA ELISA Kit,

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  Class 3 Device Recall DiaSorin AntiCardiolipin IgA ELISA Kit, see related information
Date Initiated by Firm November 01, 2004
Date Posted June 25, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall Number Z-0927-05
Recall Event ID 30950
510(K)Number K001981  
Product Classification System, Test, Anticardiolipin Immunological - Product Code MID
Product DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom.
Code Information Catalog no. 7800, lots FS1123 and FS2184
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact DiaSorin Technical Service
800-328-1482
Manufacturer 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).
FDA Determined
Cause 2		 Other
Action Customers were notifed of the product and the problem and were advised to destroy any remaining inventory and replacements were offered.
Quantity in Commerce 49
Distribution NY, KS, GA & MT
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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