Class 2 Device Recall Human Lambda Free SPAPlus Kit

• Date Initiated by Firm: November 28, 2012
• Date Posted: January 19, 2017
• Recall Status: Terminated 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
• FEI Number: 3002808340
• 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: 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