FDA-Device2016-07-20Class III
enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
Ortho-Clinical Diagnostics
Hazard
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.
Sold states
Nationwide
Affected count
US: 30 units
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2143-2016Don't want to check this manually?
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