FDAFDA · Food and drugs·Recall number Z-2918-2018
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.
Published August 29, 2018 · Recall initiated: February 14, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Decreasing performance overtime.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Euro Diagnostica AB
- Distributor
- Minnesota and Texas Foreign: Iran
- Lot
- Lot # RS 3092, SS 1737
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
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