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U.S. Department of Health and Human Services

Class 2 Device Recall Human Lambda Free SPAPlus Kit

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  Class 2 Device Recall Human Lambda Free SPAPlus Kit see related information
Date Initiated by Firm November 28, 2012
Date Posted January 19, 2017
Recall Status1 Terminated 3 on March 03, 2017
Recall Number Z-1050-2017
Recall Event ID 76049
510(K)Number K062372  
Product Classification Lambda, antigen, antiserum, control - Product Code DEH
Product Human Lambda Free SPAPlus Kit

Product Code: LK018.S

Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
Code Information Lot #323278, 327963
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		 Calibration curve activity has increased over time in the kit lots listed.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Customer notification letters were sent 11/28/12. Customers were asked to discontinue using the listed kit lots. Discard any unused or partially-used kits of these lots. Let The Binding Site know how many replacement kits are required.
Quantity in Commerce 1,002
Distribution U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain.
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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