Ortho Clinical Diagnostics Inc Recall 87019
Description: VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293
Ortho Clinical Diagnostics Inc Recall 87019 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0845-2021 |
| Event ID | 87019 |
| Event Description | VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of AR, AU, BM, BR, CA, CL, CN, CO, CR, DO, EC, FR, FR, GT, HT, IN, JP, MX, PA, PE, PR, PY, SV. |
| Quantity | US=9802; OUS: 1298 Total: 11,100 |
| Recall Reason | Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides |
| Device Classification | 20210120 |
| Device Code Info | All Current, Future and Past Lots UDI: 10758750031771 |
| Center Classification Date | 20210112 |
| Recall Initiation Date | 20201215 |
| Recalling Firm | Ortho Clinical Diagnostics Inc |
| Initial Notification | Letter |
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