Recall Z-1642-2022— OXFORD IMMUNOTEC LTD

Name: FDA recall Z-1642-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-07

Class II · Ongoing

Class II FDA medical device recall by OXFORD IMMUNOTEC LTD, initiated 2022-07-07. FDA's recall record names no specific 510(k) clearance for this event. Product: T-Cell Xtend REF TTK.610 US. 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..

Recalling firm: OXFORD IMMUNOTEC LTD
Classification: Class II
Status: Ongoing
Initiated: 2022-07-07
Firm location: Abingdon, United Kingdom

Product description

T-Cell Xtend REF TTK.610 US

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.