FDA-Device2022-09-07Class II

AIM-V Medium REF AV.200/500

OXFORD IMMUNOTEC LTD
Hazard

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.

Sold states
U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None
Affected count
6 units
Manufactured in
143 Park Road, Abingdon, United Kingdom
Products
AIM-V Medium REF AV.200/500

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1643-2022

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