Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 4/10/2025
Class II
PRODUCT
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223
Recall Number:
Z-1551-2025
REASON:
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
RECALLING FIRM/MANUFACTURER:
Siemens Healthcare Diagnostics, Inc.
VOLUME:
N/A
DISTRIBUTION:
Domestic: Nationwide Distribution. International: Australia, Austria, Bahamas, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Curacao, Seus, 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, Vatican City.
