Class II

Medical Device Recall: ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)

Siemens Healthcare Diagnostics, Inc. · June 4, 2025

Reason for Recall

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

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.

States Affected

NATIONWIDE

Quantity Affected

4,214 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2087-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Siemens Healthcare Diagnostics, Inc. Medical Device Recall: ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) | SafeCheck