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Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Recalled April 16, 2025 · FDA recall Z-1551-2025 · Siemens Healthcare Diagnostics
Hazard
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result. · FDA Class II
Units
N/A
Sold at
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.¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿ ¿¿¿¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿ ¿¿¿¿¿¿
Description
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
Product
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →