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U.S. Department of Health and Human Services

Class 3 Device Recall DIASTAT antiScl70 test

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  Class 3 Device Recall DIASTAT antiScl70 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-2922-2018
Recall Event ID 80684
510(K)Number K912291  
Product Classification Antinuclear antibody, antigen, control - Product Code LKJ
Product is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
Code Information Lot #'s: TS 1740 (kit) and TS 1743 (PC)
Recalling Firm/
Manufacturer		 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 4
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 = LKJ and Original Applicant = SHIELD DIAGNOSTICS, LTD.
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