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.
FDA Recall Z-0929-2018 · Posted None
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Recalling FirmEuro Diagnostica AB
Recall StatusTerminated
Product CodeLKJ
Date Initiated2015-10-15
Date Terminated2019-03-29
Product Quantity1090
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.
Firm 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 .
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution and US. Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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