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U.S. Department of Health and Human Services

Class 2 Device Recall Immunoscan CCPlus test kit

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  Class 2 Device Recall Immunoscan CCPlus test kit see related information
Date Initiated by Firm February 14, 2016
Date Posted August 23, 2018
Recall Status1 Terminated 3 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
Recalling Firm/
Manufacturer		 Euro Diagnostica AB
Box 50117
Lundavagen 151
Malmo Sweden
Manufacturer Reason
for Recall		 Decreasing performance overtime.
FDA Determined
Cause 2		 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 and Original Applicant = EURO-DIAGNOSTICA AB
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