Class 2 Device Recall Optilite Rheumatoid Factor Kit

• Date Initiated by Firm: October 07, 2019
• Create Date: May 22, 2020
• Recall Status: Terminated on January 11, 2022
• Recall Number: Z-2110-2020
• Recall Event ID: 85366
• 510(K)Number: K162263
• Product Classification: System, test, rheumatoid factor - Product Code DHR
• Product: Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
• Code Information: Kit Lot Number: 428224
• Recalling Firm/ Manufacturer: The Binding Site Group, Ltd.; 8 Calthorpe Road; Birmingham United Kingdom
• Manufacturer Reason for Recall: Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment.
• FDA Determined Cause: Process control
• Action: The field safety notice was issued from the firm's UK office to their US office. The US office notified affected end users in the US via Field Safety Notice, dated 09 October 2019 that was sent via email on 9 Oct 2019. The FSN stated the following: 1) That it has been identified that the assigned Rheumatoid Factor (RF) calibrator value, for LK151.0PT.A lot 428224, over recovers by 7% in comparison to the reference material RF serum, NIBSC. Ref 64/002 (WHO Standard 64/2). 2) The firm has assessed risk of this over recovery and determined that there is no clinical risk, and that the kit can continue to be used providing the control results are within their specified acceptance ranges. There is however, a risk of reporting abnormal results which may lead to unnecessary additional serological testing. 3) Although the affected kit, lot 428224, may continue to be used, The Binding Site has calculated an adjustment factor of 0.93 that may be applied to sample results in order to align results to the reference material. They advise that to apply the adjustment factor, the final result for the sample should be multiplied by 0.93. Calibrator and control values for future lots of LK151.0PT.A, will be aligned with the reference material. 4) An e-back form (TSWS18) was provided to affected customers along with the FSN. The FSN requests the customer to complete, sign and return the e-back form to Technical.Support@bindingsite.com or to their local Binding Site representative within one week of receiving the notification to confirm that they have received and understood the FSN. 5) If further information is required, contact local Binding Site Representative or Technical Support Group, UK: +44(0) 1214569696, Technical.support@bindingsite.com
• Quantity in Commerce: 478 kits
• Distribution: US: AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI OUS: None
• 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 = DHR and Original Applicant = THE BINDING SITE GROUP LTD.