T-Cell Xtend Test Kit Recalled Due to Improper Storage Temperature
Oxford Immunotec is recalling 47 units of the T-Cell Xtend REF TTK.610 US test kit due to equipment failure that caused improper storage temperatures outside the validated range. Affected devices may have been compromised.
What this means for you
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: This FDA Class II recall involves a diagnostic test device stored outside validated temperature range due to equipment failure. Although no illnesses or injuries have been reported, a test kit with potentially compromised performance constitutes a risk-of-harm product, meeting the threshold for High severity.
Plain-English summary
Oxford Immunotec has recalled 47 units of the T-Cell Xtend REF TTK.610 US test kit (Model/Catalog Number: TTK.610 US, Lot Number: 1001). The recall was issued because equipment failure resulted in these products being stored at temperatures outside the validated range of 2-8 degrees Celsius for a period longer than the validated storage time.
The affected units were distributed to locations in Alabama, California, the District of Columbia, Georgia, Indiana, Oregon, and Washington.
Due to the improper storage conditions, the performance and safety of these devices may have been affected. Healthcare providers and patients who have received these devices should verify the lot number and model to determine if they have affected product.
The recalled product
- Product
- T-Cell Xtend REF TTK.610 US
- Manufacturer
- OXFORD IMMUNOTEC LTD
- Hazard
- improper-storage
- temperature-excursion
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model/Catalog Number: TTK.610 US UDI-DI Code: 15051716000022 Lot Number: 1001
Distribution
Distributed in 7 states:
- AL
- CA
- DC
- GA
- IN
- OR
- WA
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