Class II

Medical Device Recall: ADVIA¿ 120/2120/2120i SETpoint Calibrator

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

2,020 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2086-2025

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.