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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

OXFORD IMMUNOTEC LTD: 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.

Agency Publication Date: August 26, 2022
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Affected Products

Product: T-SPOT.TB REF TB.300 US

Model/Catalog Number: TB.300 US UDI-DI Code: 15051716000305 Lot Number: TEC4000098

Lot Numbers:
15051716000305
Number
Product: T-Cell Xtend REF TTK.610 US

Model/Catalog Number: TTK.610 US UDI-DI Code: 15051716000022 Lot Number: 1001

Lot Numbers:
15051716000022
Number
Product: AIM-V Medium REF AV.200/500

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

Lot Numbers:
Not
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90654
Status: Active
Manufacturer: OXFORD IMMUNOTEC LTD
Manufactured In: United Kingdom
Units Affected: 3 products (81 units; 47 units; 6 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.