Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C-Reactive Protein (RCRP)

The potential for falsely elevated results.

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

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 with your laboratory records and forward this letter to those who may have received the affected product.

• FDA enforcement recordOfficial FDA database entry for Z-3335-2026
• FDA 510(k) clearance · K221119The device's official FDA premarket clearance record
• FDA device classification · DCNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.5270The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Siemens Healthcare Diagnostics, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.