Recall – Immunoassay analyzer settings can be corrupted

Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 5/7/2020
Class II

PRODUCT

Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower

Recall Number: Z-1797-2020

REASON

Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.

RECALLING FIRM/MANUFACTURER

Siemens Healthcare Diagnostics, Inc. on 2/27/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

1807

DISTRIBUTION

US Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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