Recall – Lab data management system software issues

Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 4/24/2019
Class II:

PRODUCT

syngo Lab Data Manager System – Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data Center. It supports the Siemens analyzers through delivery of applications and connectivity features.

Recall Number: Z-1195-2019

REASON

Software Issues.

RECALLING FIRM/MANUFACTURER

Siemens Healthcare Diagnostics, Inc. on 8/26/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
449 systems

DISTRIBUTION

US Nationwide and International

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62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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