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Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)

Recalled July 9, 2025 · FDA recall Z-2087-2025 · Siemens Healthcare Diagnostics

Hazard
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. · FDA Class II
Units
4,214 units
Sold at
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.

Description

Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

Product
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) | RecallWatchUSA