Events

Rappel de Liquid Urine Control Level 3

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 Randox Laboratories.

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
    77152
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2167-2017
  • Date de mise en oeuvre de l'événement
    2017-04-27
  • Date de publication de l'événement
    2017-05-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155040
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Cause
    According to randox laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of total protein (urine). the values for the mean of all instruments are incorrect by a factor of 10. instrument specific values are correct. this does not affect the performance or stability claims of the product. as control results will be outside of the quoted range this may result in a delay in reporting the sample test results. however as the correct instrument specific means are also included in the value sheet this delay is unlikely. customers have been referred to their medical director for further advice.
  • Action
    Randox Laboratories will contact Customers directly by e-mail and will be followed up with once every 2 weeks over a period of 6 weeks. There are no plans in place to follow up with customers after the 6 week period. For further questions, please call (304) 728-2890.

Device

Liquid Urine Control Level 3
  • Modèle / numéro de série
    Catalogue number UC5075 Batch number 907UC
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution to Puerto Rico and to the countries of : Canada Kuwait Chile Poland China Romania France Saudi Arabia Guatemala Slovenia Iran UAE India UK Italy Uruguay Iraq
  • Description du dispositif
    Liquid Urine Control Level 3 || For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
  • Manufacturer
    Randox Laboratories

Manufacturer

Randox Laboratories
  • Adresse du fabricant
    Randox Laboratories, 515 Industrial Blvd, Kearneysville WV 25430-2778
  • Société-mère du fabricant (2017)
    Randox Holdings Limited
  • Source
    USFDA