Siemens Healthcare Diagnostics, Inc.: System, Test, C-reactive Protein
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
- Reason
- The potential for falsely elevated results.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-17
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/0f0644b4-bd13-42e1-bfd5-db3edef896e5