Oxford Immunotec recalls T-SPOT.TB REF TB.300 US due to improper storage temperatures risking product effectiveness. 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-SPOT.TB REF TB.300 US test kits because they were stored at incorrect temperatures for too long. This could make the test kits less effective or fail to detect tuberculosis accurately.
The test kits were stored at temperatures outside the required 2-8°C range for a period longer than the validated storage time. This could reduce the test's accuracy or effectiveness, potentially leading to false results.
People who own or use T-SPOT.TB REF TB.300 US test kits for tuberculosis testing. Those who stored the kits outside the 2-8°C range for longer than validated time are most at risk.
Check for the model number TB.300 US on the test kit packaging. The lot number TEC4000098 and UDI-DI code 15051716000305 are also associated with this recall.
Ensure the test kits were stored within 2-8°C for the validated time period before use.
The test kits were stored at temperatures outside the validated 2-8°C range for longer than the validated storage time, which could reduce effectiveness.
Check for the model number TB.300 US on the packaging and lot number TEC4000098.
Ensure the test kits were stored within 2-8°C for the validated time period before use. No specific action is required beyond this check.
We’ve drafted a message you can send Oxford Immunotec to request your refund or repair — edit it as you like.
Subject: Recall Z-1641-2022 — Oxford Immunotec Oxford Immunotec Hello, I own a Oxford Immunotec that is covered by recall Z-1641-2022 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.
