Z-1551-2025Class II

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

Name: Z-1551-2025 Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2025-03-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-03-11 / Open, Classified / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223 on 2025-03-11. FDA classified it as Class II and gives the reason as "Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1551-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-11
Posted: 2025-04-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Product code: DCN System, Test, C-Reactive Protein
Reason for recall: Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
Root cause tag: software
FDA root cause: Software Design Change
Action: On March 11, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Customer Actions " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. " For both Atellica CH and Atellica CI analyzers, perform the instructions in Appendix B to temporarily reduce the measuring interval. o Until the measuring interval is restored, track additional reagent consumption as a result of these actions to report to Siemens Healthineers for future reimbursement/credit. " Additionally, for Atellica CH Analyzers, perform the instructions in Appendix C to remove rules for flagging of No Calculation results and to install Atellica Solution Software version 1.29.0 or higher. " Complete and return the Field Correction Effectiveness Check form attached to this letter within 30 days. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Resolution A follow-up communication will be provided when Customer Actions are no longer required. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Distribution: Domestic: Nationwide Distribution. International: Australia, Austria, Bahamas, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark,¿Estonia, Finland, France, Germany, Greece,¿Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithuania, Malaysia, Maldives, Netherlands, New Zealand, Norway, Oman,¿Pakistan, Poland, Portugal, Qatar, Romania, Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South¿Africa, Spain, Sweden, Switzerland, Taiwan, U.A.E., Uganda, United¿Kingdom, Uzbekistan, Vatikancity.¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿ ¿¿¿¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿ ¿¿¿¿¿¿
Product codes and lots: Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1551-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1551-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-10

Product code DCN

K221119Class IIRCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc. / cleared 2023-03-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)