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U.S. Department of Health and Human Services

Class 2 Device Recall FREELITE" Human Lambda Free Kit for use on the SPAplus"

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  Class 2 Device Recall FREELITE" Human Lambda Free Kit for use on the SPAplus" see related information
Date Initiated by Firm October 28, 2016
Date Posted January 19, 2017
Recall Status1 Terminated 3 on July 27, 2017
Recall Number Z-1053-2017
Recall Event ID 76050
510(K)Number K062372  
Product Classification Lambda, antigen, antiserum, control - Product Code DEH
Product Freelite Human Lambda Free Kit for use on SPAPLUS

Product Code: LK018.S, LK018.10S
Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
Code Information Lot #400012, 400257
Recalling Firm/
Manufacturer		 The Binding Site Group, Ltd.
8 Calthorpe Road
Birmingham United Kingdom
For Additional Information Contact Germaine Schwider
858-4539177
Manufacturer Reason
for Recall		 A change in the calibration curve causing an increase in false prozone flags.
FDA Determined
Cause 2		 Under Investigation by firm
Action Binding Site sent an Important Notice dated October 28, 2016, to all affected customers. . Binding Site requests the following: - Immediately quarantine and dispose of any LK018.S lot 400012 / LK018.10S lot 400257 kits held in your organisation; - Remove any affected lots from the SPAPLUS instrument; - Contact Binding Site representative to request replacement kits; - Return completed E-back form to your local Binding Site representative. For questions regarding this recall call 858-453-9177.
Quantity in Commerce 3,088
Distribution Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.
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 = DEH and Original Applicant = THE BINDING SITE, LTD.
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