Euro Diagnostica AB: Medical Device Recall in 2018 - (Recall #: Z-2918-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 14, 2016

Date Posted: August 29, 2018

Recall Number: Z-2918-2018

Event ID: 80689

Reason for Recall:

Decreasing performance overtime.

Status: Terminated

Product Quantity: 25 kits (US only)

Code Information:

Lot # RS 3092, SS 1737

Distribution Pattern:

Minnesota and Texas Foreign: Iran

Voluntary or Mandated:

Voluntary: Firm initiated