ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
FDA Recall #Z-2087-2025 — Class II — June 4, 2025
Product Description
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 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
4,214 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 10330063; UDI: 00630414473406, 00630414473406; Lot No. TP251035, TP251045.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated