Class 2 Device Recall TCell Xtend

• Date Initiated by Firm: July 07, 2022
• Create Date: August 26, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1642-2022
• Recall Event ID: 90654
• Product Classification: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test - Product Code OJN
• Product: T-Cell Xtend REF TTK.610 US
• Code Information: Model/Catalog Number: TTK.610 US UDI-DI Code: 15051716000022 Lot Number: 1001
• Recalling Firm/ Manufacturer: OXFORD IMMUNOTEC LTD; 143 Park Road; Abingdon United Kingdom
• Manufacturer Reason for Recall: Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.
• FDA Determined Cause: Storage
• Action: On 07/07/2022, Oxford Immunotec Limited send a Field Safety Notice to customers informing them that the firm has become aware that products distributed may have been stored outside of the storage specifications for a short period. Customer are asked to quarantined the affected products until further notice. On 07/13/2022, the firm communicated a follow-up "URGENT ACTION REQUIRED" Letter to customer asking to confirm that affected products have been segregated into a quarantine area and have not been used to produce patient results. On 07/20/2022, the firm sent a "VOLUNTARY PRODUCT RECALL NOTIFICATION" informing customers that Oxford Immunotec Limited is conducting a full recall of the affected products and asking customers to now destroy the affected products following these steps: 1. Ensure Recalled Product remains in Quarantine. As per our previous communication dated July-13-2022, please ensure all stock of the above products remain in a secure location pending destruction. 2. Complete Tracking/Verification Form. Complete and return the enclosed tracking/verification form, following the directions on this page and the Tracking/Verification Form. Your Oxford Immunotec sales representative can assist you in completing the form. 3. Indicate Destroyed Products on Tracking/Verification Form. The tracking/verification form lists the [product name] and product descriptions. Please mark the number of each type of [product] that you are destroying on this form. On or after 08/03/2022, Oxford Immunotec Ltd communicated an updated/follow-up customer notification with included the potential risks/harms/hazards associated with the use of the affected products. For questions or assistance - contact Chris Dark at +44 1235 442780 or Maureen Garner at 855-NWRS-222 (855-697-7222), or alternatively any Oxford Immunotec Sales Representatives.
• Quantity in Commerce: 47 units
• Distribution: U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.