Euro Diagnostica AB recalls DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitati…

Recall date

May 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2627-2017

FDA classification

Class III

Brand / firm

Euro Diagnostica AB

Sold / distributed

MN, TX, NE, PA, Spain, Egypt, Pakistan, Nepal, Canada

Why it was 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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.