Company:Ortho-Clinical Diagnostics
Date of Enforcement Report:6/18/2014
Class lI:
PRODUCT
enGen (TM) Laboratory Automation System Configured with TCAutomation” Software v3.5 — For in vitro quantitative measurement of a variety of analytes of clinical interest — The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.). —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. By using the enGen (TM) Laboratory Automation System as a communication interface between the LIS and the clinical analyzers in the laboratory, the user can manage the workflow to the analyzers and other devices as an integrated system. This eliminates the need for the user to program tests for each sample uniquely on each analyzer. Within the enGen (TM) Laboratory Automation System, the physical routing of samples to the correct location is also automatic. The Buffer Module functions either as a location for samples waiting for results or as a storage area for empty sample tube carriers. When a sample is presented to a clinical analyzer via the Bypass module and is metered for testing, the sample remains on the track system in the Buffer module while waiting for the test results to be generated. If all test results are generated as expected and no additional actions are required, the sample is routed to a designated Exit module where it can be removed from the track system by the user. However, there are certain situations in which a follow-up action (retest of the sample) may be necessary. In these situations, the sample is routed back to a clinical analyzer via the Bypass module to complete the follow-up action. Examples of situations requiring a retest include, but are not limited to: repeat testing when a “No Result”is generated during the initial test event, sample dilution when an out of range result is obtained during the initial test event, and routing to an alternate analyzer when the first analyzer the sample is sent to is unavailable for testing. Once the follow-up sample metering actions are complete, the sample is routed to Buffer module where it remains until testing is complete. Once all test results are obtained the sample is routed to the designated Exit module.
Recall Number Z-1741-2014
REASON
Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5.
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 4/17/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Domestic: 6 units, Foreign: 3 units
DISTRIBUTION
Nationwide and Internationally
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