Z-2918-2018Class II

Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and...

Name: Z-2918-2018 Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and...
Creator: Euro Diagnostica AB
Published: 2016-02-14
License: https://open.fda.gov/license/

Svar Life Science AB / initiated 2016-02-14 / Terminated / root cause: manufacturing process

FDA source

Euro Diagnostica AB began a recall of Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic... on 2016-02-14. FDA classified it as Class II and gives the reason as "Decreasing performance overtime". 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-2918-2018
Classification: Class II
Status: Terminated
Initiated: 2016-02-14
Posted: 2018-08-23
Terminated: 2019-11-05
Recalling firm: Svar Life Science AB
Product: Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.
Product code: NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Reason for recall: Decreasing performance overtime.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: None
Quantity in commerce: 25 kits (US only)
Distribution: Minnesota and Texas Foreign: Iran
Product codes and lots: Lot # RS 3092, SS 1737

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2918-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2918-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-23

Product code NHX

K091657Class IIImmunoscan CcplusEuro-Diagnostica AB / cleared 2009-11-19

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)