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.
FDA Recall Z-2627-2017 · Posted None
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Recalling FirmEuro Diagnostica AB
Recall StatusTerminated
Product CodeLKJ
Date Initiated2017-05-22
Date Terminated2021-03-31
Product Quantity501 units
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.
Firm Action
The firm initiated the problem by email on 05/22/2017. The consignee was directed to destroy the product.
Root Cause
Other
Distribution Pattern
MN, TX, NE, PA, Spain, Egypt, Pakistan, Nepal, Canada
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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