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U.S. Department of Health and Human Services

Class 3 Device Recall DIASTAT anticardiolipin IgG test

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  Class 3 Device Recall DIASTAT anticardiolipin IgG test see related information
Date Initiated by Firm October 21, 2016
Date Posted August 23, 2018
Recall Status1 Terminated 3 on November 05, 2019
Recall Number Z-2920-2018
Recall Event ID 80684
510(K)Number K001574  
Product Classification System, test, anticardiolipin immunological - Product Code MID
Product is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders
Code Information Lot #'s: TS 2783 (kit) and TS 2787 (PC)
Recalling Firm/
Euro Diagnostica AB
Box 50117
Lundavagen 151
Malmo Sweden
Manufacturer Reason
for Recall
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
FDA Determined
Cause 2
Error in labeling
Action none
Quantity in Commerce 6
Distribution MN
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