Events

Rappel de Device Recall VERIFYNOWP2Y12 ASSAY

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 Accumetrics Inc.

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
    61761
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1854-2012
  • Date de mise en oeuvre de l'événement
    2012-02-06
  • Date de publication de l'événement
    2012-06-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-11-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109704
  • 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
    System, automated platelet aggregation - Product Code JOZ
  • Cause
    The recall was initiated by accumetrics because of a field correction to the verifynow system; specifically the results reported when running the verifynow p2y12 test. currently the verifynow p2y12 test reports three values: pru, base and % inhibition. the change implemented is the elimination of the base and % inhibition results. there will be no change to the reporting of the pru result whic.
  • Action
    Accumetrics, Inc. sent an Urgent Field Correction notification letter and an Ackknowledgement - fax back form to all affected customers. The letter identifed the affected product, problem and actions to be taken. The letter informed customers that an Accumetrics representative will be contacting them to schedule an appointment to update their VerifyNow instrument software. The letter stated that Accumetrics realizes that procedures and report format may need to be revised as software changes is implemented, and will provide assistance to help in making this transition. For any questions or concerns, call at 1-800-643-1640 ext. 2; or email at: support@accumetrics.com.

Device

Device Recall VERIFYNOWP2Y12 ASSAY
  • Modèle / numéro de série
    Not available
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    VerifyNow System, part #85005-6H || Product Usage: || The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
  • Manufacturer
    Accumetrics Inc

Manufacturer

Accumetrics Inc
  • Adresse du fabricant
    Accumetrics Inc, 3985 Sorrento Valley Blvd Ste B, San Diego CA 92121-1497
  • Société-mère du fabricant (2017)
    Werfenlife Sa.
  • Source
    USFDA