FDAClass IISeptember 7, 2022

AIM-V Medium recall

AIM-V Medium REF AV.200/500

Why was AIM-V Medium recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
AIM-V Medium REF AV.200/500
Recalling firm
OXFORD IMMUNOTEC LTD
Quantity
6 units
Distribution
U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None
Recall date
September 7, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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