Atellica CH Revised C-Reactive Protein (RCRP)
The potential for falsely elevated results.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Siemens Healthcare Diagnostics, Inc. recalled its Atellica CH Revised C-Reactive Protein (RCRP) product, Siemens Material Number 11537223, due to the potential for falsely elevated results. The recall began on August 17, 2026, and was classified by the FDA on September 30, 2026, with the company recalling 42,940 units total, including 3,938 in the U.S. and 39,002 outside the U.S.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
- UDI-DI
- 11537223
- 00630414610887
- Lot
- All lots;
Details
- Company began the recall
- Sold in
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.
- Event ID
- 99726
- Recall No.
- Z-3335-2026
- Company
- Siemens Healthcare Diagnostics, Inc.Tarrytown, New York
- Hazard
- Device defect
- Quantity recalled
- 42940 units (3938 US, 39002 OUS)
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
