FDAFDA · Food and drugs·Recall number Z-2089-2025
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Published July 9, 2025 · Recall initiated: June 4, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- 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.
- Lot
- Siemens Material Number 10318905; UDI: 00630414473413, 00630414473413; Lot No. TP253035, TP253045.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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