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Recall Observatory FDA recall evidence

Device product

ADVIA¿ 120/2120/2120i SETpoint Calibrator

Z-2086-2025

June 04, 2025

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 97037
Status
Ongoing
Classification
Class II
Quantity
2,020 units
Official record key
device-enforcement:Z-2086-2025

Official wording

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

Code information: Siemens Material Number 10312285; UDI: 00630414224343, 00630414224343; Lot No. SP251033, SP251043.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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