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Open, Classified

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

FDA Recall Z-3335-2026 · Posted 2026-10-01

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeDCN
Date Initiated2026-08-17
Product Quantity42940 units (3938 US, 39002 OUS)

Reason for Recall

The potential for falsely elevated results.

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

Root Cause

Under Investigation by firm

Distribution Pattern

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, Germany, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., Uganda, United Kingdom , Uruguay, Uzbekistan, Vatikancity, Vietnam, Zaire.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc. · 2023-03-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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