Reported Jul 20, 2016 · Terminated
enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom…
Ortho-Clinical Diagnostics
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
- Lot codes and dates
- Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above
- Serial Numbers/J Numbers
JIM341866JIM341820JIM341679JIM341352JIM343421JIM341174JIM336745JIM340667JIM338283JIM-341592JIM336957JIM341996JIM342334JIM343694JIM336855JIM334236JIM341415JIM341392JIM336481JIM340934JIM336167JIM342249JIM338290JIM341750JIM341426JIM334986JIM334527JIM340024JIM341021JIM340658
- Amount recalled
- US: 30 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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