Z-0306-2018Class II

Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA...

Name: Z-0306-2018 Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA...
Creator: Euro Diagnostica AB
Published: 2017-02-14
License: https://open.fda.gov/license/

Svar Life Science AB / initiated 2017-02-14 / Terminated / root cause: manufacturing process

FDA source

Euro Diagnostica AB began a recall of Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for... on 2017-02-14. FDA classified it as Class II and gives the reason as "Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0306-2018
Classification: Class II
Status: Terminated
Initiated: 2017-02-14
Posted: 2017-12-20
Terminated: 2018-05-16
Recalling firm: Svar Life Science AB
Product: Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.
Product code: LKJ Antinuclear Antibody, Antigen, Control
Reason for recall: Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were notified by phone or email beginning 2/15/2017. The Urgent Field Safety Notice identified affected product, described the issue, and stated affected product should be destroyed. A response form was asked to be returned. Questions can be directed to Malin Bornschein at [email protected]
Quantity in commerce: 534 kits
Distribution: MN, NE, TX
Product codes and lots: Lot: TS 2076

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0306-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0306-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2017-12-29

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)