Recall Z-1551-2025— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1551-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-11

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2025-03-11. It names one FDA 510(k) clearance: K221119. Product: Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.. Reason: Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-03-11
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

Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.

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