Recall – Chemistry analyzer calibration values have drifted out of specification

Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 2/26/2020
Class II


ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator – product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay.

  • Recall Number: Z-1260-2020


Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.


Siemens Healthcare Diagnostics, Inc. Voluntary:  Firm Initiated recall is ongoing.




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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

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