Class 2 Device Recall Human IgM Kit for use on SPAPLUS

• Date Initiated by Firm: November 06, 2018
• Date Posted: December 13, 2018
• Recall Status: Terminated on April 27, 2021
• Recall Number: Z-0604-2019
• Recall Event ID: 81421
• 510(K)Number: K082129
• Product Classification: Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
• Product: Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S; ; The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.
• Code Information: Lot 413849
• Recalling Firm/ Manufacturer: The Binding Site Group, Ltd.; 8 Calthorpe Road; Birmingham United Kingdom
• Manufacturer Reason for Recall: Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.
• FDA Determined Cause: Under Investigation by firm
• Action: On 11/06/2018, the firm, The Binding Site, emailed an "Urgent Medical Device Correction notice" and Field Correction E-back Form to customers. The notice described the product, problem and actions to be taken. Customers were instructed to do the following: 1) Reagents are to be loaded on-board the analyser and left for a minimum of 18 hours prior to running the calibration and validating the curve. Please leave the reagents on-board the analyser until empty. 2) Once calibration is established and validated, reagents must remain on the instrument until the reagent has been fully consumed. 3) When not in use the control vials and calibrator sets should be removed from the instrument, be capped to avoid evaporation and stored at 2-8 degrees C. 4) To be able to accept the calibration curve and to use the assay to report test results, the control materials to be tested at a minimum once a day should return results within ¿15% of the concentration(s) as stated on the accompanying QC certificate. If a control measurement is out of range when assayed with a stored curve the assay must be recalibrated. If on recalibration the control values measured with the new curve are still out of range, the instrument and the assay parameters should be checked before repeating the assay. 5) If calibration issues are still experienced when following this advice please do not hesitate to contact a firm representative. The E-back Form requests that each customer sign the form confirming they have both received and have followed the advice issued in the Notification; and return completed E-back form to technical.support@bindingsite.com or your local Binding Site Representative. This notice needs to be passed on all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred. Customers with additional questions are encouraged to contact their local firm representative, or customer service via phon
• Quantity in Commerce: 60
• Distribution: U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,
• 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 = CFN and Original Applicant = THE BINDING SITE, LTD.