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.