Class 2 Device Recall Optilite CReactive Protein Kit

• Date Initiated by Firm: February 19, 2019
• Date Posted: December 12, 2019
• Recall Status: Terminated on April 27, 2021
• Recall Number: Z-0671-2020
• Recall Event ID: 84243
• 510(K)Number: K172868
• Product Classification: System, test, c-reactive protein - Product Code DCN
• Product: Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.
• Code Information: Model Number: NK044.OPT.A Lot 437705 UDI 05051700018449 Medical Device Listing number D317086
• Recalling Firm/ Manufacturer: The Binding Site Group, Ltd.; 8 Calthorpe Road; Birmingham United Kingdom
• Manufacturer Reason for Recall: Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
• FDA Determined Cause: Material/Component Contamination
• Action: On 02/19/2019 an "URGENT FIELD SAFETY NOTICE" was communicated to the US customers informing them of an observed deterioration of the CRP NK044.OPT.A reagent material, lot number 437705 and that the Recalling firm has made the decision to remove the affected product lot from the market.. The Customers are instructed to: -Discontinue using the product immediately and to remove any remaining affected reagents from the Optilite instrument. -Dispose of any remaining product at the customer's facility following local regulations, -The Recalling Firm considers this issue is unlikely to impact on medical management, they are recommending that the information be discussed with the customer's medical director so that potential Impact of the issue is considered on a local level. -Customer are to complete, sign and return the E-Back Form TSWS18 to Technical.support@bindingsite.com or to their local representative within one week of receiving the notification. A witness signature of the kit disposal is required on the E-Back Form. The notification also states to: -Distribute the notice to all those who need to be aware of the matter within the customer's organization. -Transfer the notice to any other organization on which the recall action has impacted. -Maintain awareness on the notice and resulting action for appropriate period to ensure effectiveness of the recommended actions. For any questions or further information - contact the local firm representative or call +44(0) 1214569696
• Quantity in Commerce: 10 kits
• Distribution: US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS
• 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 = DCN and Original Applicant = The Binding Site Group Ltd.