Abingdon, United Kingdom
OXFORD IMMUNOTEC LTD recalls
2 recalls recorded since 2018, most recently on 7 July 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 July 2022
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1642-2022, Z-1641-2022, Z-1643-2022
- T-Cell Xtend REF TTK.610 US
- T-SPOT.TB REF TB.300 US
- AIM-V Medium REF AV.200/500
Terminated Class III Medical devices
- Recall started
- 16 July 2020
- Terminated
- 13 September 2021
- Reason
- Incorrect expiration date included in test kit labeling and/or in Substrate component label.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AL, CO, D.C., GA, ID, IN, MD, OH, PA, TN, TX, and VA. The countries of Austria, Belgium, Czech Republic, France, Germany, Italy, Kuwait, Latvia, Netherlands, Philippines, Saudi Arabia, Singapore, South Korea, Spain, Swe
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2976-2020, Z-2977-2020
- Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulatio
- Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulatio
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.