Recall Z-2627-2017— Euro Diagnostica AB

Name: FDA recall Z-2627-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-22

Class III · Terminated

Class III FDA medical device recall by Euro Diagnostica AB, initiated 2017-05-22, terminated 2021-03-31. It names one FDA 510(k) clearance: K932876. Product: 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.. Reason: 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..

Recalling firm: Euro Diagnostica AB
Classification: Class III
Status: Terminated
Initiated: 2017-05-22
Terminated: 2021-03-31
Firm location: Malmo, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K932876 — DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KITShield Diagnostics, Ltd.·cleared 1993-11-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.