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U.S. Department of Health and Human Services

Class 2 Device Recall AIMV Medium

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  Class 2 Device Recall AIMV Medium see related information
Date Initiated by Firm July 07, 2022
Create Date August 26, 2022
Recall Status1 Open3, Classified
Recall Number Z-1643-2022
Recall Event ID 90654
Product Classification Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test - Product Code OJN
Product AIM-V Medium REF AV.200/500
Code Information Model/Catalog Number: AV.200/500 UDI-DI Code: Not yet assigned Lot Number: 100380
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 2		 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 6 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.
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