ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Reported: July 9, 2025 Initiated: June 4, 2025 #Z-2088-2025
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 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.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control). Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 3,435 units.
Why was this product recalled? ▼
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 9, 2025. Severity: Moderate. Recall number: Z-2088-2025.
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