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Recall Observatory FDA recall evidence

Device product

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

Z-1944-2014

May 20, 2014

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 68394
Status
Terminated
Classification
Class II
Quantity
336
Official record key
device-enforcement:Z-1944-2014

Official wording

Reason: 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.

Code information: syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.