Events

Rappel de Device Recall STRATIFY JCV DxSelect

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 Focus Diagnostics 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
    70856
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1454-2015
  • Date de mise en oeuvre de l'événement
    2015-03-15
  • Date de publication de l'événement
    2015-04-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135234
  • 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
    Anti-jcv antibody detection assay - Product Code OYP
  • Cause
    Focus diagnostics is recalling the stratify jcv dx select due to the use of a non-conforming batch in the manufacture of jcv dxselect el1950 kit lot #27333. this could lead to a potential for false positive jcv results.
  • Action
    Focus Diagnostics sent an Urgent Device Customer Notification letter dated March 15, 2015, was sent to the customer to inform them that Focus Diagnostics is recalling the Stratify JCV DxSelect (EL1950) lot#27333 due to the potential for false positive JCV results. The letter informs the customer of the issues and the actions to be taken. The customer is instructed to complete the enclosed acknowledgement form and email the form to DxTS@focusdx.com or fax back to Focus Diagnostics Technical Services at (562) 240-6526 within 10 business days. If the customer has any questions or require additional information, then they are instructed to contact Focus Diagnostic's Technical Services department at (800) 838-4548, select option 3, between the hours of 7am to 5pm (PST) or send an email to DxTS@focusdx.com.

Device

Device Recall STRATIFY JCV DxSelect
  • Modèle / numéro de série
    Lot No. 27333
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Internationally: Denmark only.
  • Description du dispositif
    STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
  • Manufacturer
    Focus Diagnostics Inc

Manufacturer

Focus Diagnostics Inc
  • Adresse du fabricant
    Focus Diagnostics Inc, 11331 Valley View St, Cypress CA 90630-5366
  • Source
    USFDA