| Class 2 Device Recall AIMV Medium | |
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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