Z-2918-2018 Class II Terminated
FDA device recall Z-2918-2018 was initiated by Euro Diagnostica AB on February 14, 2016 and is designated Class II. Reason for recall: Decreasing performance overtime. The recall status is terminated (terminated November 5, 2019). Affected quantity: 25 kits (US only).
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