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

PRODUCT

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

REASON

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

RECALLING FIRM/MANUFACTURER

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

VOLUME OF PRODUCT IN COMMERCE

2405 units

DISTRIBUTION

U.S. 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.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.