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.

This recall has been terminated (originally issued May 22, 2017).

Company: Euro Diagnostica Ab
Recall Initiated: May 22, 2017
Terminated: March 31, 2021
Recall Number: Z-2627-2017
Quantity: 501 units
Firm Location: Malmo Sweden
Official Source: View on FDA website ↗

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.