Rappel de enGen (TM) Laboratory Automation System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ortho-Clinical Diagnostics.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    68269
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1741-2014
  • Date de mise en oeuvre de l'événement
    2014-04-17
  • Date de publication de l'événement
    2014-06-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2017-04-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    Software anomaly: potential buffer timeout issues when using engen (tm) laboratory automation systems configured with tcautomation (tm) software v3.5.
  • Action
    Ortho Clinical Diagnostics sent an Important Product Correction Notification dated April 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. On April 17, 2014, foreign affiliates were informed by e-mail of the issue and instructed to notify their customers of the issue and actions. The letters instruct customers: to ensure that samples prematurely routed to Check are detected and processed appropriately, please monitor completion of all pending tests following standard laboratory practice. Customers were informed of the issue and advised to: -- Routinely monitor pending result reports from your Laboratory Information System (LIS) to determine if results are pending for samples. -- Investigate to determine the next action identified for a sample if the sample is routed to the Check location prematurely. If you have any additional questions, please call Customer Technical Services at 1-800-421-3311.

Device

  • Modèle / numéro de série
    enGen (TM) Laboratory Automation Systems configured with TCAutomation" Software version 3.5
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including the states of Arizona, Delaware, Ohio, Tennessee, and North Carolina; and the countries of Mexico, England and Italy.
  • Description du dispositif
    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.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Société-mère du fabricant (2017)
  • Source
    USFDA