Events

Rappel de KASSAY Alpha1 Microglobulin Reagent

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 Kamiya Biomedical Company, LLC.

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
    50074
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0923-2011
  • Date de mise en oeuvre de l'événement
    2008-09-17
  • Date de publication de l'événement
    2011-01-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74651
  • 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
    Alpha-1 microglobulin, antigen, antiserum, control - Product Code MGA
  • Cause
    Standardization of the reagent performance data did not match the standardization used to assign the calibrator values.
  • Action
    Kamiya Biomedical Company, LLC sent an urgent medical Device Recall letter dated September 17, 2008, and the corrected package insert via e-mail. . The letter identified the product, the problem, and the action the customer should take. Customers were instructed to replace their previous package inserts with the corrected version and asked to sign and FAX the letter back once that had been completed. As one customer is also a distributor, the recalling firm told the this distributor's representative to advise their single customer of this correction and replace the package insert, and return the signed letter back to the firm. On September 22, 2008, both customers were contacted by phone and reminded to fax the signed letters once completed. For questions regarding this recall call 1-800-222-0342.

Device

KASSAY Alpha1 Microglobulin Reagent
  • Modèle / numéro de série
    Lot number 418041, catalog number KAI-056.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Kits were distributed to one laboratory in MN and to one distributor in PA who further distributed product to one customer.
  • Description du dispositif
    K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged in a kit box along with with the package insert. || The package insert is labeled in part: "K-ASSAY Alpha-1 Microglobulin...Cat. No. KAI-056...For the Quantitative Determination of human Alpha-1 Microglobulin in urine, serum, and plasma...KAMIYA BIOMEDICAL COMPANY...12779 Gateway Drive...Seattle, WA 98168 USA...".
  • Manufacturer
    Kamiya Biomedical Company, LLC

Manufacturer

Kamiya Biomedical Company, LLC
  • Adresse du fabricant
    Kamiya Biomedical Company, LLC, 12779 Gateway Dr S, Tukwila WA 98168-3308
  • Société-mère du fabricant (2017)
    Kamiya Biomedical Company Llc
  • Source
    USFDA