Home / Recalls / Euro Diagnostica AB / Z-2918-2018

Z-2918-2018 Class II Terminated

Recalled by Euro Diagnostica AB — Malmo

Recall Details

Product Type
Devices
Report Date
August 29, 2018
Initiation Date
February 14, 2016
Termination Date
November 5, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25 kits (US only)

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.

Reason for Recall

Decreasing performance overtime.

Distribution Pattern

Minnesota and Texas Foreign: Iran

Code Information

Lot # RS 3092, SS 1737

Other recalls by Euro Diagnostica AB

  • Z-2627-2017 Class III — DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuc (May 22, 2017)
  • Z-0306-2018 Class II — Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti- (February 14, 2017)
  • Z-2920-2018 Class III — is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the (October 21, 2016)
  • Z-2919-2018 Class III — is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the (October 21, 2016)
  • Z-2921-2018 Class III — is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the (October 21, 2016)
  • Z-2922-2018 Class III — is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay ( (October 21, 2016)
  • Z-0929-2018 Class II — DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200 (October 15, 2015)