Class 2 Device Recall Atellica CH Revised C Reactive Protein

• Date Initiated by Firm: March 11, 2025
• Date Posted: April 10, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1551-2025
• Recall Event ID: 96440
• 510(K)Number: K221119
• Product Classification: System, test, c-reactive protein - Product Code DCN
• Product: Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
• Code Information: Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots.
• FEI Number: 2432235
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 511 Benedict Ave; Tarrytown NY 10591-5005
• For Additional Information Contact: Syreeta Wynn; 914-413-5428
• Manufacturer Reason for Recall: Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
• FDA Determined 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.¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿ ¿¿¿¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿ ¿¿¿¿¿¿
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DCN