Urgent Field Safety Notice ACHC 25-07.A.OUS: Potential for Falsely Depressed Results with the Atellica CH UCFP Assay (Aug-2025)

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Manufacturer-issued field safety notice addressing an intermittent risk of falsely depressed results in the Atellica CH UCFP assay, outlining mandatory quality control configuration changes, retesting procedures, and confirmation of corrective actions by affected laboratories.

Year: 2025

Date Issued: Aug-2025

Document Type: Urgent Field Safety Notice

Reference Number: ACHC 25-07.A.OUS

Product: Atellica CH Urinary/Cerebrospinal Fluid Protein Assay (UCFP)

Test Code: UCFP

Siemens Material Number: 11097543

Unique Device Identification: 00630414279206

Lot Number: All lots

Affected Systems: Atellica CH Analyzer; Atellica CI Analyzer

Manufacturer: Siemens Healthcare Diagnostics Inc.

Organization: Siemens Healthineers

Single Registration Number (SRN): US-MF-000016560

Issue: Potential for falsely depressed patient, QC, and calibration results in initial replicate(s) of a freshly punctured reagent well stored onboard

Maximum Observed Negative Bias: -19.0 mg/dL (-190 mg/L)

Sample Types: Urine; Cerebrospinal Fluid (CSF)

Required Actions: Update QC settings, enable QC on Pack Change, enable Patient QC Flagging, repeat testing of flagged results, change well status if QC fails, complete and return Field Correction Effectiveness Check Form within 30 days

Appendix: Detailed customer instructions for QC configuration and well status changes

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