OXFORD IMMUNOTEC LTD Recall 90654
Description: T-Cell Xtend REF TTK.610 US
OXFORD IMMUNOTEC LTD Recall 90654 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1642-2022 |
| Event ID | 90654 |
| Event Description | T-Cell Xtend REF TTK.610 US |
| Product Type | Devices |
| Distribution | U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None |
| Quantity | 47 units |
| Recall Reason | 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. |
| Device Classification | 20220907 |
| Device Code Info | Model/Catalog Number: TTK.610 US UDI-DI Code: 15051716000022 Lot Number: 1001 |
| Center Classification Date | 20220826 |
| Recall Initiation Date | 20220707 |
| Recalling Firm | OXFORD IMMUNOTEC LTD |
| Initial Notification | Letter |
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