Recall Z-2086-2025— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2086-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-04

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2025-06-04. It names one FDA 510(k) clearance: K840261. Product: ADVIA¿ 120/2120/2120i SETpoint Calibrator. Reason: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-04
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K840261 — CAL-CHEX, A HEMATOLOGY CALIBRATORStreck Laboratories, Inc.·cleared 1984-02-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ADVIA¿ 120/2120/2120i SETpoint Calibrator

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.