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U.S. Department of Health and Human Services

Class 2 Device Recall Euro Diagnostica DIASTAT ANA (antinuclear antibody)

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  Class 2 Device Recall Euro Diagnostica DIASTAT ANA (antinuclear antibody) see related information
Date Initiated by Firm February 14, 2017
Date Posted December 20, 2017
Recall Status1 Terminated 3 on May 16, 2018
Recall Number Z-0306-2018
Recall Event ID 77107
510(K)Number K932876  
Product Classification Antinuclear antibody, antigen, control - Product Code LKJ
Product Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA

DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.
Code Information Lot: TS 2076
Recalling Firm/
Manufacturer		 Euro Diagnostica AB
Box 50117
Lundavagen 151
Malmo Sweden
For Additional Information Contact Malin Bornschein
4640537600
Manufacturer Reason
for Recall		 Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were notified by phone or email beginning 2/15/2017. The Urgent Field Safety Notice identified affected product, described the issue, and stated affected product should be destroyed. A response form was asked to be returned. Questions can be directed to Malin Bornschein at malin.bornschein@eurodiagnostica.com
Quantity in Commerce 534 kits
Distribution MN, NE, TX
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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