• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall DiaSorin AntiCardiolipin IgA ELISA Kit,

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  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/
Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact DiaSorin Technical Service
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
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.