T.Cell Xtend®
Oxford Immunotec, Inc. · Model TTK.650 · UDI-DI 15051716000053
Description
Approval for the use of t-cell xtend reagent with the t-spot. Tb test, in order to extend the time from sample collection to sample processing from within 8 hours of venipuncture to between 23 and 30 hours post venipuncture; and to make a technical correction to the t-spot. Tb test package insert to change the number of blood collection tubes required from (2) 6 ml heparin tubes to (1) 6 ml heparin tube. The t-cell xtend reagent is indicated for use with the t-spot. Tb test for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25 degrees c).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-07 | OXFORD IMMUNOTEC LTD | 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. |
| 2022-07-07 | OXFORD IMMUNOTEC LTD | 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. |
| 2022-07-07 | OXFORD IMMUNOTEC LTD | 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. |
| 2020-07-16 | Oxford Immunotec | Incorrect expiration date included in test kit labeling and/or in Substrate component label. |
| 2020-07-16 | Oxford Immunotec | Incorrect expiration date included in test kit labeling and/or in Substrate component label. |
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