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.
This recall has been terminated (originally issued August 23, 2018).
- Company
- Euro Diagnostica Ab
- Recall Initiated
- February 14, 2016
- Posted
- August 23, 2018
- Terminated
- November 5, 2019
- Recall Number
- Z-2918-2018
- Quantity
- 25 kits (US only)
- Firm Location
- Malmo Sweden
- Official Source
- View on FDA website ↗
Reason for Recall
Decreasing performance overtime.
Distribution
Minnesota and Texas Foreign: Iran
Lot / Code Info
Lot # RS 3092, SS 1737
Root Cause
Nonconforming Material/Component
Action Taken
None
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