Device product
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Z-2088-2025
Product summary
- Event
- Event 97037
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,435 units
- Official record key
device-enforcement:Z-2088-2025
Official wording
Reason: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Code information: Siemens Material Number 10316217; UDI: 00630414473390, 00630414473390; Lot No. TP252035, TP252045.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA.
Derived failure modes
-
Unknown
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.