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U.S. Department of Health and Human Services

Class 2 Device Recall Beta2Microglobulin Urine Kit

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  Class 2 Device Recall Beta2Microglobulin Urine Kit see related information
Date Initiated by Firm March 09, 2018
Create Date April 03, 2018
Recall Status1 Terminated 3 on June 22, 2020
Recall Number Z-1301-2018
Recall Event ID 79499
510(K)Number K122066  
Product Classification System, test, beta-2-microglobulin immunological - Product Code JZG
Product Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K.

The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings.
Code Information Lot 407460, UDI 05051700017688
Recalling Firm/
Manufacturer		 The Binding Site Group, Ltd.
8 Calthorpe Road
Birmingham United Kingdom
For Additional Information Contact
800-633-4484
Manufacturer Reason
for Recall		 The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm notified their U.S. location by letter dated 3/6/2018 via email on 3/9/2018.
Quantity in Commerce 20 kits distributed to the U.S.
Distribution US Distribution was made to CA. There was no foreign/military/government distribution.
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 = JZG and Original Applicant = THE BINDING SITE GROUP LTD
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