Oxford Immunotec recalls T-SPOT.TB8 TB test kits with incorrect expiration dates on labels or substrate components. Affected kits may not be reliable for tuberculosis diagnosis.
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
Oxford Immunotec is recalling T-SPOT.TB8 tuberculosis test kits that have incorrect expiration dates on their labels or substrate components. Using these kits could lead to inaccurate test results, which might affect diagnosis of tuberculosis infection.
The test kits have incorrect expiration dates on their labels or substrate components. This could cause the test to give inaccurate results, potentially leading to missed diagnoses of tuberculosis infection.
People who purchased or use T-SPOT.TB8 test kits with the specified model and catalog numbers for tuberculosis testing are affected. Those who rely on these kits for accurate TB diagnosis are at higher risk of incorrect results.
Check for model number T-SPOT.TB8, catalog number TB.300, and unique device identifier 1505171600030 on the test kit packaging. The kits were sold with specific manufacturing kit lot numbers: TEC3321847 and TEC3041811.
Look for the model number T-SPOT.TB8, catalog number TB.300, and unique device identifier 1505171600030 on the test kit packaging.
The test kits have incorrect expiration dates on their labels or substrate components, which could lead to inaccurate tuberculosis test results.
Check the kit for the model number T-SPOT.TB8, catalog number TB.300, and unique device identifier 1505171600030. If it matches, contact Oxford Immunotec for guidance.
No safety risks are associated with using the test kit; the issue is with potential inaccurate results due to incorrect expiration dates.
We’ve drafted a message you can send Oxford Immunotec to request your refund or repair — edit it as you like.
Subject: Recall Z-2976-2020 — Oxford Immunotec Oxford Immunotec Hello, I own a Oxford Immunotec that is covered by recall Z-2976-2020 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.
