Events

Rappel de SoftLab

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 SCC Soft Computer.

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
    60405
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0261-2012
  • Date de mise en oeuvre de l'événement
    2011-08-08
  • Date de publication de l'événement
    2011-11-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-11-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105257
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Cause
    On 08/08/2011 scc soft computer, clearwater, fl initiated a correction on following softlab used with: sa base 3.1.4.X, 3.1.6.X and sa labmic 4.0.0.X, 4.0.1.X, 4.0.2.X, 4.0.3.X, 4.0.4.X. a client reported a flagging error where the result was flagged as critical in the instrument menu but the printed report did not show the corresponding flag. all affected clients were notified of the issue on 0.
  • Action
    SCC Soft Computer notified all affected customers on August 8, 2011, of the recall via the SCC Soft Computer proprietary Task management system to manage client communication. Clients use this tool to log in requests for services and receive and provide updates to any issue. Each client user has a unique password and every action is date and time-stamped. Each Task has a unique identifier and a full audit trail. SCC recommended to the customer until Live on the correction avoid making edits in the instrument menu. For further questions please call (727) 789-0100.

Device

SoftLab
  • Modèle / numéro de série
    Versions: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA ( nationwide) and Canada.
  • Description du dispositif
    Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. || SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.
  • Manufacturer
    SCC Soft Computer

Manufacturer

SCC Soft Computer
  • Adresse du fabricant
    SCC Soft Computer, 5400 Tech Data Drive, Clearwater FL 33760
  • Société-mère du fabricant (2017)
    Soft Computer Consultants Inc.
  • Source
    USFDA