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Recall Observatory FDA recall evidence

Device product

enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD

Z-2143-2016

May 16, 2016

Class III

Product summary

Firm
Ortho-Clinical Diagnostics
Event
Event 74354
Status
Terminated
Classification
Class III
Quantity
US: 30 units
Official record key
device-enforcement:Z-2143-2016

Official wording

Reason: If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the IM incorrectly displays the interpretive text as Borderline and sends the incorrect text to the LIS. The IFU states the interpretation term for these numerical result values is Retest?.¿ The difference in terminology exists for US Markets only.

Code information: Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; Serial Numbers/J Numbers: JIM341866, JIM341820, JIM341679, JIM341352, JIM343421, JIM341174, JIM336745, JIM340667, JIM338283, JIM-341592, JIM336957, JIM341996, JIM342334, JIM343694, JIM336855, JIM334236, JIM341415, JIM341392, JIM336481, JIM340934, JIM336167, JIM342249, JIM338290, JIM341750, JIM341426, JIM334986, JIM334527, JIM340024, JIM341021, JIM340658

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the IM incorrectly displays the interpretive text as Borderline and sends the incorrect text to the LIS. The IFU states the interpretation term for these numerical result values is Retest?.¿ The difference in terminology exists for US Markets only.