FDA-Device2025-04-16Class II
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Siemens Healthcare Diagnostics, Inc.
Hazard
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
Sold states
Domestic: Nationwide Distribution. International: Australia, Austria, Bahamas, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark,¿Estonia, Finland, France, Germany, Greece,¿Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithuania, Malaysia, Maldives, Netherlands, New Zealand, Norway, Oman,¿Pakistan, Poland, Portugal, Qatar, Romania, Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South¿Africa, Spain, Sweden, Switzerland, Taiwan, U.A.E., Uganda, United¿Kingdom, Uzbekistan, Vatikancity.¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿ ¿¿¿¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿ ¿¿¿¿¿¿
Affected count
N/A
Manufactured in
511 Benedict Ave, N/A, 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-1551-2025Don't want to check this manually?
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