Class 2 Device Recall Immunoscan CCPlus test kit

• Date Initiated by Firm: February 14, 2016
• Date Posted: August 23, 2018
• Recall Status: Terminated on November 05, 2019
• Recall Number: Z-2918-2018
• Recall Event ID: 80689
• 510(K)Number: K091657
• Product Classification: Antibodies, anti-cyclic citrullinated peptide (ccp) - Product Code NHX
• 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.
• Code Information: Lot # RS 3092, SS 1737
• FEI Number: 3007610287
• Recalling Firm/ Manufacturer: Euro Diagnostica AB; Box 50117; Lundavagen 151; Malmo Sweden
• Manufacturer Reason for Recall: Decreasing performance overtime.
• FDA Determined Cause: Nonconforming Material/Component
• Action: None
• Quantity in Commerce: 25 kits (US only)
• Distribution: Minnesota and Texas Foreign: Iran
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NHX