FDA Recall: Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.

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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.