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Terminated

syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.

FDA Recall Z-1944-2014 · Posted 2014-06-30

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2014-05-20
Date Terminated2015-08-10
Product Quantity336

Reason for Recall

Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.

Firm Action

An urgent medical device correction notice, dated May 20, 2014, was sent to end users to provide instructions to avoid potential risks associated with the software defect, until changes can be made by a Siemens technical representative.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.

Official Source

View FDA Recall →

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

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