enGen Laboratory Automation System recall
enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
Why was enGen Laboratory Automation System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- US: 30 units
- Distribution
- Nationwide
- Recall date
- July 20, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)