Device product
VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292
Z-0844-2021
Product summary
- Event
- Event 87019
- Status
- Terminated
- Classification
- Class II
- Quantity
- US= 223,788 ; OUS:=168,120 Totlal: 491,908
- Official record key
device-enforcement:Z-0844-2021
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: 10758750004850
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