Events

Rappel de Device Recall iChemVELOCITY Automated Urine Chemistry System

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 Iris Diagnostics.

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
    71780
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2441-2015
  • Date de mise en oeuvre de l'événement
    2015-07-15
  • Date de publication de l'événement
    2015-08-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139050
  • 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
    Automated urinalysis system - Product Code KQO
  • Cause
    Iris international is recalling the ichemvelocity systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at 20-80% relative humidity (rh) as stated in the ichemvelocity product labeling.
  • Action
    An Urgent Medical Device Recall letter dated 7/15/15 was sent to all customers who purchased the iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips REF 800-7212 and 800-7212-001. As a result of internal investigations following customer complaints, Iris International has determined that the iChemVELOCITY systems do not maintain the on-board strip stability claim of 5 days at 18-28¿C at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions or concerns regarding the recall notice, are instructed to contact Beckman Coulter Customer Support at http://www.beckmancoulter.com or call (800) 526-7694 in US and Canada.

Device

Device Recall iChemVELOCITY Automated Urine Chemistry System
  • Modèle / numéro de série
    All Serial Numbers
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Jordan, Republic of Korea, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Description du dispositif
    iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.
  • Manufacturer
    Iris Diagnostics

Manufacturer

Iris Diagnostics
  • Adresse du fabricant
    Iris Diagnostics, 9172 Eton Ave, Chatsworth CA 91311-5805
  • Source
    USFDA