Euro Diagnostica AB: Medical Device Recall in 2017 - (Recall #: Z-2627-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: May 22, 2017

Date Posted: July 5, 2017

Recall Number: Z-2627-2017

Event ID: 77426

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.

Status: Terminated

Product Quantity: 501 units

Code Information:

TS 3577

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated