Z-0929-2018Class II

DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200

Name: Z-0929-2018 DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200
Creator: Euro Diagnostica AB
Published: 2015-10-15
License: https://open.fda.gov/license/

Svar Life Science AB / initiated 2015-10-15 / Terminated / root cause: manufacturing process

FDA source

Euro Diagnostica AB began a recall of DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT anti-nuclear antibody (ANA) test is a qualitative... on 2015-10-15. FDA classified it as Class II and gives the reason as "Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM conjugate, and the low...". 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-0929-2018
Classification: Class II
Status: Terminated
Initiated: 2015-10-15
Posted: 2018-03-08
Terminated: 2019-03-29
Recalling firm: Svar Life Science AB
Product: DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT 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.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.
Product code: LKJ Antinuclear Antibody, Antigen, Control
Reason for recall: Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample test results for the two FANA200 kit lots SS 1500 and SS 2009.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Euro Diagnostica sent a Customer notifications letter to affected customers via email on 10/15/2015. The letter identified the affected product problem and actions to be taken. For question contact Euro Diagnostica .
Quantity in commerce: 1090
Distribution: Worldwide Distribution and US. Nationwide
Product codes and lots: UDI: 07340058410486. Lot numbers: SS 1500 and SS 2009.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0929-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0929-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-08

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)