Summary
The FDA issued a Class II for AIM-V Medium REF AV.200/500 by OXFORD IMMUNOTEC LTD. 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 valid.
Details
Source
Device Recall
External ID
Z-1643-2022
Action Date
2022-09-07
Status
Ongoing
Category
device
Product Description
AIM-V Medium REF AV.200/500
Lot/Code Info: Model/Catalog Number: AV.200/500 UDI-DI Code: Not yet assigned Lot Number: 100380
Quantity Affected: 6 units
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.
Distribution
U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-07
Company
Abingdon
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
OXFORD IMMUNOTEC LTD has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (OXFORD IMMUNOTEC LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does OXFORD IMMUNOTEC LTD have FDA actions?
OXFORD IMMUNOTEC LTD has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1643-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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