TB Diagnostic Test Recalled Due to Storage Temperature Excursion
Oxford Immunotec recalled 81 T-SPOT.TB diagnostic test kits (Lot TEC4000098) due to storage equipment failure that kept products outside the validated 2-8°C temperature range. The excursion may affect test accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a diagnostic test for a serious infectious disease where storage failure presents risk of test failure and potential missed diagnoses. No illnesses or injuries have been reported, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Oxford Immunotec has recalled 81 units of T-SPOT.TB REF TB.300 US diagnostic test kits (Lot TEC4000098) due to a storage equipment failure. The affected products were stored at temperatures outside the validated range of 2-8 degrees Celsius for a period longer than the device's validated storage duration.
The T-SPOT.TB is an in vitro diagnostic test used to detect tuberculosis infection. Products stored outside validated temperature ranges may not perform as intended, potentially affecting test accuracy and reliability.
Affected units were distributed to medical facilities in Alabama, California, Washington DC, Georgia, Indiana, Oregon, and Washington. No illnesses or injuries related to this recall have been reported.
Anyone who has received or used one of these test kits should contact Oxford Immunotec or their distributor for replacement or guidance on proper handling of potentially affected units.
The recalled product
- Product
- T-SPOT.TB REF TB.300 US
- Manufacturer
- OXFORD IMMUNOTEC LTD
- Affected units
- 81
Distribution
Part of a larger recall action
This product is one of 3 recalled by OXFORD IMMUNOTEC LTD under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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