Z-2089-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 9, 2025
- Initiation Date
- June 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,266 units
Product Description
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Reason for Recall
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
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.
Code Information
Siemens Material Number 10318905; UDI: 00630414473413, 00630414473413; Lot No. TP253035, TP253045.