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

Medical deviceClass IIOngoing

Summary: Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;. Reason: The potential for falsely elevated results.

What is being recalled

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

Why

The potential for falsely elevated results.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

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. (states named: Georgia)

How to tell if yours is affected

Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots;

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Siemens Healthcare Diagnostics, Inc. · all medical device recalls · recalls from August 2026

Official FDA record