T-Cell Xtend REF TTK.610 US
Reported: September 7, 2022 Initiated: July 7, 2022 #Z-1642-2022
Product Description
T-Cell Xtend REF TTK.610 US
Reason for Recall
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.
Details
- Recalling Firm
- OXFORD IMMUNOTEC LTD
- Units Affected
- 47 units
- Distribution
- U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None
- Location
- Abingdon
Frequently Asked Questions
What product was recalled? ▼
T-Cell Xtend REF TTK.610 US. Recalled by OXFORD IMMUNOTEC LTD. Units affected: 47 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2022. Severity: Moderate. Recall number: Z-1642-2022.
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