Oxford Immunotec recalls AIM-V Medium REF AV.200/500 due to potential temperature storage issues. Affected units stored outside 2-8°C range longer than validated time. No remedy specified in recall notice.
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.
Oxford Immunotec is recalling AIM-V Medium REF AV.200/500 products because they may have been stored at incorrect temperatures for too long. This could affect the product's safety and effectiveness, but the recall does not include a specific fix or return process.
The products were stored outside the validated temperature range of 2-8°C for longer than the approved time. This could cause the product to become unstable or ineffective, potentially leading to safety issues if used improperly.
People who own or use AIM-V Medium REF AV.200/500 products are likely affected. Those storing these products in environments that don't maintain 2-8°C temperatures are at higher risk.
Check for the model number AV.200/500 on the product label. The product was sold with lot number 100380. The exact UDI-DI code is not yet assigned.
Look for the model number AV.200/500 and lot number 100380 on the product label.
The recall notice does not specify any remedy or action steps for affected products.
The products should be stored between 2-8°C, but the recall states they were stored outside this range for longer than validated time.
Check for the model number AV.200/500 and lot number 100380 on the product label.
We’ve drafted a message you can send Oxford Immunotec to request your refund or repair — edit it as you like.
Subject: Recall Z-1643-2022 — Oxford Immunotec Oxford Immunotec Hello, I own a Oxford Immunotec that is covered by recall Z-1643-2022 from Oxford Immunotec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
