Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2086-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

ADVIA¿ 120/2120/2120i SETpoint Calibrator

Product Classification:

Class II

Date Initiated: June 4, 2025

Date Posted: July 9, 2025

Recall Number: Z-2086-2025

Event ID: 97037

Reason for Recall:

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

Status: Ongoing

Product Quantity: 2,020 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated