Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA Recalled by Euro Diagnostica AB Due to FANA200 kit lot TS 3577 was re-worked due...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Euro Diagnostica AB directly.
Affected Products
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.
Quantity: 501 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 4 states: MN, NE, PA, TX
About Euro Diagnostica AB
Euro Diagnostica AB has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report