FDA-Device2025-07-09Class II
ADVIA¿ 120/2120/2120i SETpoint Calibrator
Siemens Healthcare Diagnostics, Inc.
Hazard
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Sold states
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.
Affected count
2,020 units
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
ADVIA¿ 120/2120/2120i SETpoint Calibrator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2086-2025Don't want to check this manually?
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