Recall Z-3335-2026— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-3335-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-17

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2026-08-17. It names one FDA 510(k) clearance: K221119. Product: Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;. Reason: The potential for falsely elevated results..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-08-17
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K221119 — RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.·cleared 2023-03-17

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

Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;

Reason for recall

The potential for falsely elevated results.

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