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Terminated

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.

FDA Recall Z-1195-2019 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2015-08-26
Date Terminated2020-03-24
Product Quantity449 systems

Reason for Recall

Software Issues.

Firm Action

Siemens mailed an Urgent Field Safety Notice and an Urgent Field Correction Letter to affected customers on 08/26/2015 to inform them of the issue. The reason for the correction, risk to health and actions to be taken were explained in the notice.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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