FDA recall Z-2918-2018

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.

Reason for recall

Decreasing performance overtime.

Distribution

Minnesota and Texas Foreign: Iran

Key facts

Status

Terminated

Initiation date

2016-02-14

Report date

2018-08-29

Termination date

2019-11-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malmo, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2918-2018