Events

Rappel de Device Recall Lipase

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 Ltd..

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
    79767
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1631-2018
  • Date de mise en oeuvre de l'événement
    2018-03-02
  • 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=163324
  • 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
    Lipase hydrolysis/glycerol kinase enzyme, triglycerides - Product Code CDT
  • Cause
    Randox has now released further steps to avoid contamination of the lipase assay on rx instruments.
  • Action
    On March 1, 2018 Randox Laboratories Ltd. sent a Urgent Medical Device Correction Notification to affected customers. These customers were instructed to: 1) Update the user manual for the RX Instrument with the attached technical bulletin; 2) Replace the Instructions for Use contained within the kit with the revised version; 3) Discuss the contents of this notice with your Medical Director; 4) Complete and return the vigilance response section of this form to technical.services@randox..com within five working days; 5) Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. Customer with questions may contact Randox Technical Services via e-mail technical.services@randox.com or by phone +44 (0) 28 9445 1070

Device

Device Recall Lipase
  • Modèle / numéro de série
    Lot numbers: 428000, 404175, and 404245
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of West Virginia and Puerto Rico
  • Description du dispositif
    Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 || Product Usage: || For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
  • Manufacturer
    Randox Laboratories Ltd.

Manufacturer

Randox Laboratories Ltd.
  • Adresse du fabricant
    Randox Laboratories Ltd., 55 Diamond Road, Crumlin (North) Ireland
  • Société-mère du fabricant (2017)
    Randox Holdings Limited
  • Source
    USFDA