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U.S. Department of Health and Human Services

Class 3 Device Recall DIASTAT(R) ANA (antiNuclear antibody) EURO

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  Class 3 Device Recall DIASTAT(R) ANA (antiNuclear antibody) EURO see related information
Date Initiated by Firm May 22, 2017
Create Date October 11, 2018
Recall Status1 Terminated 3 on March 31, 2021
Recall Number Z-2627-2017
Recall Event ID 77426
510(K)Number K932876  
Product Classification Antinuclear antibody, antigen, control - Product Code LKJ
Product DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.
Code Information TS 3577
Recalling Firm/
Manufacturer		 Euro Diagnostica AB
Box 50117
Lundavagen 151
Malmo Sweden
For Additional Information Contact Rene van de Zande
512-327-9970
Manufacturer Reason
for Recall		 FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated. The original kit box label remained on the kit box stating the original expiration date, the packaging did not display the correct expiration date.
FDA Determined
Cause 2		 Other
Action The firm initiated the problem by email on 05/22/2017. The consignee was directed to destroy the product.
Quantity in Commerce 501 units
Distribution MN, TX, NE, PA, Spain, Egypt, Pakistan, Nepal, Canada
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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