Ortho-Clinical Diagnostics: Medical Device Recall in 2016 - (Recall #: Z-2143-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: May 16, 2016

Date Posted: July 20, 2016

Recall Number: Z-2143-2016

Event ID: 74354

Reason for Recall:

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.

Status: Terminated

Product Quantity: US: 30 units

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

Voluntary or Mandated:

Voluntary: Firm initiated