Events

Rappel de Device Recall iChem(R) VELOCITY Urine Chemistry Strips

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 Beckman Coulter 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
    79857
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1893-2018
  • Date de mise en oeuvre de l'événement
    2017-12-04
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163764
  • 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
    Test, urine leukocyte - Product Code LJX
  • Cause
    A subset of lot 7212154 a of the ichem velocity urine chemistry strips has an incorrect pad placed in the location of the leukocytes pad. this will result in control cb failure for leukocytes and may generate false negative erroneous results for leukocytes.
  • Action
    The firm initiated the recall by letter on 12/04/2017. The letter identified the affected product, problem and the actions to be taken. The firm requested destruction of the recalled product.

Device

Device Recall iChem(R) VELOCITY Urine Chemistry Strips
  • Modèle / numéro de série
    Lot #7212154 A
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution and US Nationwide Distribution
  • Description du dispositif
    iChem VELOCITY Urine Chemistry Strips, REF 800-7212 || Product Usage: || The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones, and ascorbic acid; and qualitative results for nitrites, color, and clarity. iChem VELOCITY strips are intended for use with the iCHEM VELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChem VELOCITY is not intended to be used as a Point of Care (POC) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iCHEM VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA