Recall Z-3335-2026 · DCN System, Test, C-Reactive Protein
Siemens Healthcare Diagnostics, Inc.
Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
| Date | Oct 1, 2026 (initiated Aug 17, 2026) |
| Status | Open, Classified |
| Reason | The potential for falsely elevated results. |
| Root cause | Under Investigation by firm |
| Action | On August 17, 2026 Urgent Medical Device Correction letters were sent to customers. Customer actions: 1. Follow the instructions provided to set-up and calibrate the device. 2. Record the number of unused tests discarded in Step 3 on the Field Correction Effectiveness Check form for reimbursement or credit. 3. Review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 4. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 5. Retain this letter |
| Quantity | 42940 units (3938 US, 39002 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, |
| 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 |