Device product
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
Z-0845-2021
Product summary
- Event
- Event 87019
- Status
- Terminated
- Classification
- Class II
- Quantity
- US=9802; OUS: 1298 Total: 11,100
- Official record key
device-enforcement:Z-0845-2021
Official wording
Reason: Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
Code information: All Current, Future and Past Lots UDI: 10758750031771
Distribution pattern: 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.
Derived failure modes
-
Unknown
Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides