Atellica CH CRP (Siemens) – software flagging error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Siemens Material Number (SMN): 11537223, UDI-DI: 00630414610887, Lot numbers: All lots.
Products Sold
Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots.
Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223. due to Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026