Recall – IVD analyzer software errors may result in incorrect patient results

Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 1/20/2021
Class II


Atellica CH 930 Analyzer – In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 – Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.

Recall Number: Z-0861-2021


Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results.


Siemens Healthcare Diagnostics, Inc. on 12/2/2020. Voluntary:  Firm Initiated recall is ongoing.


2405 units


U.S. Nationwide and International

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