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U.S. Department of Health and Human Services

Class 2 Device Recall DIASTAT antiNuclear Antibody (ANA)/DIASTAT ANA ELISA

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  Class 2 Device Recall DIASTAT antiNuclear Antibody (ANA)/DIASTAT ANA ELISA see related information
Date Initiated by Firm October 15, 2015
Create Date March 08, 2018
Recall Status1 Terminated 3 on March 29, 2019
Recall Number Z-0929-2018
Recall Event ID 79183
510(K)Number K932876  
Product Classification Antinuclear antibody, antigen, control - Product Code LKJ
Product DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200.

Product Usage:
The DIASTAT¿ 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.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.
Code Information UDI: 07340058410486. Lot numbers: SS 1500 and SS 2009. 
Recalling Firm/
Manufacturer		 Euro Diagnostica AB
Box 50117
Lundavagen 151
Malmo Sweden
For Additional Information Contact
4640537685
Manufacturer Reason
for Recall		 Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample test results for the two FANA200 kit lots SS 1500 and SS 2009.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Euro Diagnostica sent a Customer notifications letter to affected customers via email on 10/15/2015. The letter identified the affected product problem and actions to be taken. For question contact Euro Diagnostica .
Quantity in Commerce 1090
Distribution Worldwide Distribution and US. Nationwide
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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