11

Jun

2014

enGen (TM) Laboratory Automation System Cl II

0

Company:Ortho-Clinical Diagnostics
Date of Enforcement Report:6/11/2014
Class lI:

PRODUCT

enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 — For in vitro quantitative measurement of a variety of analytes of clinical interest — Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. Recall Number Z-1677-2014

REASON
Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (Storage) prior to the completion of the necessary pending action. A delay in patient test result(s) reporting could occur as operator is not alerted that results have not been produced and that further actions are required.

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 3/20/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
Domestic: 20 units, Foreign: 61 units

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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