Class 2 Device Recall Optilite IgM Kit

• Date Initiated by Firm: July 29, 2019
• Create Date: February 19, 2020
• Recall Status: Terminated on January 13, 2022
• Recall Number: Z-1327-2020
• Recall Event ID: 84729
• 510(K)Number: K191465 K191635
• Product Classification: Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
• Product: OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
• Code Information: Lot # 422251
• Recalling Firm/ Manufacturer: The Binding Site Group, Ltd.; 8 Calthorpe Road; Birmingham United Kingdom
• For Additional Information Contact: Technical Support Group; 44-0121-4569696
• Manufacturer Reason for Recall: There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.
• FDA Determined Cause: Component design/selection
• Action: On July 29, 2019, the firm issued a "Field Safety Notice" to all consignees. The firm requested consignees do the following: 1. For kit NK012.0PT.A lot 422251, please load reagents on-board the analyser and leave overnight, or alternatively for a minimum of 18 hours, prior to running the calibration and validating the curve. The Optilite analyser holds the assay reagent (R012.0PT lot 446963) in a temperature controlled reagent carousel; please leave the reagents on-board the analyser until empty (following stability advice in the insert Section 6). 2. Customers are advised that once the calibration is established and validated,the reagents must remain on the instrument until the reagent is consumed including when re-running the calibration. Investigations on NK012.0PT.A lot 422251 have shown that inversion of the reagent vials prior to re-calibration can contribute to kit control values reporting outside the specified ranges. 3. Control and calibrator vials are held in the sample handling area of the analyser. When not in use, the control and calibrator vials should be removed from the instrument, be capped to avoid evaporation and be stored at 2-sc in the refrigerator. 4. To validate the calibration curve, the control materials must be tested a minimum of once a day and 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 should be checked before repeating the assay 5. In our laboratories we have found that following the above advice allows continued and safe running of the Optilite lgM assay, if calibration issues are still experienced when following this advice please do not hesitate to contact a Binding Site representative. Advice on action to be taken by the user: " Follow advice
• Quantity in Commerce: 3294 kits
• Distribution: CA, PA, FL, AR, SD, MA, WV, AL, GA, IL, MN, MD, AZ, NC, TN, WA, MI, NY, KY, SC, IN, OR, NE, OH, TX, VT, WA, UT, IA,
• 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