Company:Ortho-Clinical Diagnostics
Date of Enforcement Report:6/18/2014
Class lI:

PRODUCT

enGen (TM) Laboratory Automation Systems (enGen) with TCAutomation (TM) — For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. — 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. The Bypass Module is an analyzer specific module that interfaces clinical analyzers to the enGen System and allows for aspirating patient samples directly from the clinical analyzers. A sample tube carrier sensor in the Bypass Module is used to detect sample tube carriers as they leave the metering location of the Bypass. If a tube carrier is not detected within a defined period of time (6.4 seconds) the next sample to be metered may not advance for processing.
Recall Number Z-1738-2014

REASON
Software anomaly: potential for delay in the reporting of patient sample test results when using enGen (TM) Laboratory Automation Systems with TCAutomation (TM) Software v2.6, v3.2 and v3.5.

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 4/10/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
Domestic – 31 units; Foreign – 77 units

DISTRIBUTION
Nationwide and Internationally

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