Class 2 Device Recall Atellica CH Total Protein_2 (TP_2)

• Date Initiated by Firm: September 22, 2026
• Date Posted: November 06, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0365-2027
• Recall Event ID: 100035
• Product Classification: Biuret (colorimetric), total protein - Product Code CEK
• Product: Atellica CH Total Protein_2 (TP_2); Siemens Material Number (SMN): 1. 11645755 (3700 tests), 2. 11537228 (7400 tests)
• Code Information: 1. Siemens Material Number (SMN): 11645755 (3700 tests); UDI-DI: 00630414654010; All lots; 2. Siemens Material Number (SMN): 11537228 (7400 tests); UDI-DI: 00630414611082; All lots
• FEI Number: 2432235
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 511 Benedict Ave; Tarrytown NY 10591-5005
• For Additional Information Contact: Jennifer Sacks; 443-793-7288
• Manufacturer Reason for Recall: Reagent probe carryover on the Atellica CH and Atellica CI Analyzers may cause falsely elevated Hemoglobin A1c (A1c_E/A1c_H) results due to HDLC carryover (biases of 9 29% in NGSP units), and falsely depressed Direct Bilirubin 2 (DBil_2) results due to TP_2 carryover (biases of 0% to -25%), which may affect patient samples, quality control, and/or calibrator results.
• FDA Determined Cause: Software Design Change
• Action: On September 29, 2026, Urgent Medical Device Correction letters were sent to customers. Customer Actions: The Clean 2 probe wash is incorporated in the following Test Definitions Update Packages, which will be available soon: o Atellica Solution CH Test Definition Update Package Version 1.2.1 o Atellica CI Analyzer CH Test Definition Update Package Version 1.2.1 Note: Customers whose systems are connected to Siemens Remote Services (SRS) may self-install the applicable version. - To receive the updated Test Definitions, confirm that your systems are running the following commercially available system software versions: o Atellica CH Analyzer Software Version 1.31.1 o Atellica CI Analyzer Software Version 1.31.51 Note: The updated Test Definitions can be installed only after the system has been updated to the applicable system software version listed above. - Once the applicable system software version has been installed and Test Definition Update Package Version 1.2.1 becomes available on your system, follow the installation instructions in the accompanying Release Notes. - Until the applicable system software versions and Test Definitions have been installed, follow the interim instructions in Appendix B or Appendix C, depending on your current software version. - If both the applicable system software version and updated Test Definitions are already installed, no further system action is required. For instructions to verify if the Test Definition Update Package Version 1.2.1 has been installed, see Appendix D. - Complete and return the Field Correction Effectiveness Check Form attached to this letter within (30) days. - Please retain this letter with your laboratory records and forward this letter to those who may have received this product.
• Quantity in Commerce: 25210 units (8087 US, 17123 OUS)
• Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cura¿ao, Cura¿ao, St Eus, Czech Republic, Democratic Republic Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Morocco, Nepal, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., Uganda, United Kingdom , Uruguay, Uzbekistan, Vatikancity, Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.