Events

Rappel de MicroVue Bb Plus EIA

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 Diagnostic Hybrids 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
    69545
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0417-2015
  • Date de mise en oeuvre de l'événement
    2014-10-16
  • Date de publication de l'événement
    2015-09-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130895
  • 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
    Factor b, antigen, antiserum, control - Product Code JZH
  • Cause
    Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
  • Action
    Quidel sent an Urgent Medical Device Recall letter dated October 16, 2014, to all consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately review their inventory and determine if they have of the affected product. If so, they should remove it from their inventory and destroy it immediately by discarding it into their normal biomedical waste stream. Complete the enclosed Certificate of Destruction. Upon receipt of the Certificate of Destruction, Quidel, will then schedule their shipment of replacement product. If consignees further distributed the affected product, they should identify the customers and provide them with the Urgent Medical Device Recall. Consignees were instructed to monitor and reconcile the quarantine of product with the customers as this information may need to be provided to the authorities. For questions regarding this recall call 740-589-3300. For technical support consignees should contact technicalsupport@quidel.com or call 800-874-1517.

Device

MicroVue Bb Plus EIA
  • Modèle / numéro de série
    Model Number A027; Lot Number 018186;  (self-affixed, EDMA Code: 12 01 02 04 00; Complement Component Bb)
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA, including AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, and WA; and, the countries of Canada, China, India, and Switzerland.
  • Description du dispositif
    MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
  • Manufacturer
    Diagnostic Hybrids Inc

Manufacturer

Diagnostic Hybrids Inc
  • Adresse du fabricant
    Diagnostic Hybrids Inc, 1055 E State St, Suite 100, Athens OH 45701-7911
  • Société-mère du fabricant (2017)
    Quidel Corporation
  • Source
    USFDA