Events

Rappel de Variant II Turbo Hemoglobin A1C Program

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 Bio-Rad Laboratories 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
    53649
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0867-2010
  • Date de mise en oeuvre de l'événement
    2009-10-12
  • Date de publication de l'événement
    2010-02-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-12-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86262
  • 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
    Glycosylated Hemoglobin Assay - Product Code LCP
  • Cause
    Product update kit cd rom will not upload. as a result, the device cannot be run.
  • Action
    The firm initiated this action on 10/12/2009. Consignees were contacted by phone with a fax follow up. Subsidiaries, as well as consignees that received the product, were provided with a Medical Device Correction notice, dated October 13, 2009, and response form. Each subsidiary will contact customers. The letter asks customers to destroy the affected lot included with their reorder packs and replace them with the lot number that's enclosed. Customers are to complete the Customer Medical Device Correction Response Form and fax it to Bio-Rad CSD Regulatory Affairs Department at the number provided. Questions should be directed to customers' regional Bio-Rad office.

Device

Variant II Turbo Hemoglobin A1C Program
  • Modèle / numéro de série
    Lot No. 70291520.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Hong Kong, and New Zealand.
  • Description du dispositif
    Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA. || Intended Use: For the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc
  • Adresse du fabricant
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA