FDA-Device2026-10-07Class IIPROCESSING DEFECT
Siemens Atellica CH Revised C-Reactive Protein test recalled for falsely elevated results
What this means
Siemens has recalled its Atellica CH Revised C-Reactive Protein (RCRP) test kit worldwide due to the potential for falsely elevated results. This diagnostic test is used in clinical laboratories to measure inflammation levels. Laboratories using affected lots may have received inaccurate test results.
- If you operate or work in a clinical laboratory, check whether your facility uses this test kit (Material Number 11537223).
- Contact Siemens Healthcare Diagnostics or your laboratory director for guidance on affected lots and corrective actions.
- Review recent test results from this kit with your healthcare provider if you received a C-Reactive Protein test result that seemed unusually high.
The agency's original wording
Hazard
The potential for falsely elevated results.
Intended for
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
42940 units (3938 US, 39002 OUS)
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3335-2026More Siemens recalls
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