ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
FDA Recall #Z-2088-2025 — Class II — June 4, 2025
Product Description
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Reason for Recall
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Recalling Firm
Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3,435 units
Distribution
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 10316217; UDI: 00630414473390, 00630414473390; Lot No. TP252035, TP252045.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated