Medical device recalls Moderate risk

Euro Diagnostica AB recalls Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determi…

Recall date
February 14, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2918-2018
FDA classification
Class II
Brand / firm
Euro Diagnostica AB
Sold / distributed
Minnesota and Texas Foreign: Iran

Why it was recalled

Decreasing performance overtime.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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