—#147261

Product

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

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K063144
Affected lot / code info: 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

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.

Root cause (FDA determination)

Software design

Action the firm took

Ortho Clinical Diagnostics sent an "IMPORTANT PRODUCT CORRECTION NOTIFICATION" Customer Letter dated May 16, 2016, to all affected customers in the US with enGen Systems via FedEx or US Priority Mail (for Post Office Box addresses) or by e-mail to subscribers of ORTHO PLUS e-Communications to advise them of the issue and the required actions . Required Actions: 1. Use the numerical test results to assess actions to be taken for these assays, per the IFU. 2. Post this notification by your enGen System or with your user documentation. 3. Complete and return the Confirmation of Receipt form by 25 May 2016. with the Instructions for Use (IFU) directions). If you have any questions regarding this notification, please call the Ortho Technical Solutions Center at any time at 1-800-421-3311.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2016-05-16
Posted by FDA: 2016-07-08
Terminated: 2018-06-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147261. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.