Recall Z-2087-2025— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2087-2025
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: K993825. Product: ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control). 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

K993825 — PARA TECH PLUS RETICSStreck Laboratories, Inc.·cleared 1999-11-30

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 3-in-1 TESTpoint Control (ABN1 Control)

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.