Ortho-Clinical Diagnostics recalls enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2…

Recall date

May 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2143-2016

FDA classification

Class III

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

Nationwide

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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