Class 2 Device Recall Optilite Freelite Lambda Free Kit

• Date Initiated by Firm: July 05, 2016
• Date Posted: January 18, 2017
• Recall Status: Terminated on July 03, 2017
• Recall Number: Z-1043-2017
• Recall Event ID: 76048
• 510(K)Number: K150658
• Product Classification: Lambda, antigen, antiserum, control - Product Code DEH
• Product: Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
• Code Information: Lot #405566, 405567
• FEI Number: 3002808340
• Recalling Firm/ Manufacturer: The Binding Site Group, Ltd.; 8 Calthorpe Road; Birmingham United Kingdom
• Manufacturer Reason for Recall: Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards.
• FDA Determined Cause: Under Investigation by firm
• Action: On 07/05/16 notification letters were sent to customers. The Binding Site Group requests the following: - Immediately Quarantine & Dispose of any LK018.OPT lot 405566 kits within stock; - Remove any affected lots from the Optilite instrument; - Patients with Lambda Freelite results >114mg/L should be reviewed in consultation with clinicians, alongside other clinical findings and retested where applicable; - Notify local Binding Site representative to request replacement kits; - Return completed E-Back Form to local Binding Site Representative; The firm recommended that the notice be circulated to those within the organization who need to be aware.
• Quantity in Commerce: 809 kits
• Distribution: U.S. distribution to the following; AR, PA, GA, NC, KY, VA, CA. Foreign distribution to the following; Uk, Germany, France, Italy, Spain, Czech Republic, Portugal, Belgium.
• 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