Z-2627-2017Class III

DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a...

Name: Z-2627-2017 DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a...
Creator: Euro Diagnostica AB
Published: 2017-05-22
License: https://open.fda.gov/license/

Svar Life Science AB / initiated 2017-05-22 / Terminated / root cause: labeling and UDI

FDA source

Euro Diagnostica AB began a recall of DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay... on 2017-05-22. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2627-2017
Classification: Class III
Status: Terminated
Initiated: 2017-05-22
Posted: 2018-10-11
Terminated: 2021-03-31
Recalling firm: Svar Life Science AB
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.
Product code: LKJ Antinuclear Antibody, Antigen, Control
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm initiated the problem by email on 05/22/2017. The consignee was directed to destroy the product.
Quantity in commerce: 501 units
Distribution: MN, TX, NE, PA, Spain, Egypt, Pakistan, Nepal, Canada
Product codes and lots: TS 3577

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2627-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2627-2017	Class III	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-23

Product code LKJ

K932876Class IIDiastat Anti-Nuclear Antibody (Ana) KitShield Diagnostics, Ltd. / cleared 1993-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)