Recall Z-1551-2025 · DCN System, Test, C-Reactive Protein
Siemens Healthcare Diagnostics, Inc.
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
| Date | Apr 10, 2025 (initiated Mar 11, 2025) |
| Status | Open, Classified |
| Reason | Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result. |
| 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 Ate |
| 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, La |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221119 | RCRP Flex reagent cartridge Siemens Healthcare Diagnostics, Inc., Mar 17, 2023 |