Siemens Healthcare Diagnostics, Inc.: Device Recall
Recall #Z-2087-2025 · 06/04/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2087-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Status
- Ongoing
- Date Initiated
- 06/04/2025
- Location
- Tarrytown, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,214 units
Reason for Recall
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Product Description
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
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.
Other Recalls by Siemens Healthcare Diagnostics, Inc.
- Class II: Risk 10/06/2025
- Class II: Risk 10/06/2025
- Class II: Risk 10/06/2025
- Class II: Risk 09/22/2025
- Class II: Risk 08/11/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.