Oxford Immunotec recalls T-Cell Xtend REF TTK.610 US due to potential temperature storage issues affecting product stability. Affected units were stored outside 2-8°C for longer than validated time.
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 T-Cell Xtend REF TTK.610 US products because they were stored at incorrect temperatures for too long. This could affect product stability and safety for users.
The product was stored outside the required 2-8°C range for longer than the validated storage time. This could lead to instability in the product, potentially affecting its safety and effectiveness.
Users of the T-Cell Xtend REF TTK.610 US product are affected. Healthcare providers and individuals using this medical device are most at risk.
Check for the model TTK.610 US with UDI-DI code 15051716000022 and lot number 1001. The product was sold in the US market.
Identify the model TTK.610 US with UDI-DI code 15051716000022 and lot number 1001 to confirm if your product is affected.
The recall is due to potential temperature storage issues, but the product itself is not inherently dangerous. Affected units may have stability concerns.
Check for the model TTK.610 US with UDI-DI code 15051716000022 and lot number 1001. The product was sold in the US market.
The recall does not specify a remedy, so you should check product details to confirm if it's affected. Contact Oxford Immunotec for further guidance if needed.
We’ve drafted a message you can send Oxford Immunotec to request your refund or repair — edit it as you like.
Subject: Recall Z-1642-2022 — Oxford Immunotec Oxford Immunotec Hello, I own a Oxford Immunotec that is covered by recall Z-1642-2022 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.
