Z-2919-2018Class III

is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies...

Name: Z-2919-2018 is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies...
Creator: Euro Diagnostica AB
Published: 2016-10-21
License: https://open.fda.gov/license/

Svar Life Science AB / initiated 2016-10-21 / Terminated / root cause: labeling and UDI

FDA source

Euro Diagnostica AB began a recall of is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum... on 2016-10-21. FDA classified it as Class III and gives the reason as "Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin". 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-2919-2018
Classification: Class III
Status: Terminated
Initiated: 2016-10-21
Posted: 2018-08-23
Terminated: 2019-11-05
Recalling firm: Svar Life Science AB
Product: is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sjgren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
Product code: LKO Anti-Rnp Antibody, Antigen And Control
Reason for recall: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: none
Quantity in commerce: 4
Distribution: MN
Product codes and lots: Lot #'s: TS2725 (kit) and TS 2733 (PC)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2919-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2919-2018	Class III	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-23
Z-2920-2018	Class III	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-23
Z-2921-2018	Class III	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-23
Z-2922-2018	Class III	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-23

Product code LKO

K905194Class IIDiastat Anti-Ro (Ss-a)Shield Diagnostics, Ltd. / cleared 1990-12-13

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)