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Recall Observatory FDA recall evidence

Device product

AIM-V Medium REF AV.200/500

Z-1643-2022

July 07, 2022

Class II

Product summary

Firm
OXFORD IMMUNOTEC LTD
Event
Event 90654
Status
Ongoing
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-1643-2022

Official wording

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.

Code information: Model/Catalog Number: AV.200/500 UDI-DI Code: Not yet assigned Lot Number: 100380

Distribution pattern: U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.