T-Cell Xtend REF TTK.610 US
This recall is currently active, issued July 7, 2022. It was issued by Oxford Immunotec Ltd 143 Park Road Abingdon United Kingdom.
- Recall Initiated
- July 7, 2022
- Recall Number
- Z-1642-2022
- Quantity
- 47 units
- Official Source
- View on FDA website ↗
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.
Distribution
U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None
Lot / Code Info
Model/Catalog Number: TTK.610 US UDI-DI Code: 15051716000022 Lot Number: 1001
Root Cause
Storage
Action Taken
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.