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U.S. Department of Health and Human Services

Class 3 Device Recall enGen Laboratory Automation System

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 Class 3 Device Recall enGen Laboratory Automation Systemsee related information
Date Initiated by FirmMay 16, 2016
Date PostedJuly 08, 2016
Recall Status1 Terminated 3 on June 08, 2018
Recall NumberZ-2143-2016
Recall Event ID 74354
510(K)NumberK063144 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductenGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
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 
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information ContactMs. Jennifer Paine
908-218-8776
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOrtho 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.
Quantity in CommerceUS: 30 units
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JJE
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