Events

Alerte De Sécurité sur iChemVELOCITY Urine Chemistry Systems

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Iris International.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2017-04-11
  • Date de publication de l'événement
    2017-04-11
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170412a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: iris international ichemvelocity urine chemistry systems medical device manufacturer, iris international, has issued a medical device safety alert concerning its ichemvelocity automated urine chemistry systems [reference numbers: 800-3564, 800-7100, 800-7103, 800-7162, 800-7163, 800-7166, 800-3061], equipped with color/clarity/specific gravity module (cgm) [part numbers: 700-7602, 700-7611, b93997]. according to the manufacturer, the concerned ichemvelocity system detects and reports 11 colours as opposed to the 18 listed in the ichemvelocity operator’s manual. if the instrument is equipped with any of the part numbers listed above: the following urine colours will be detected and correctly reported: colourless, straw, light yellow, yellow, dark yellow, light amber, amber, dark amber, red, blue, and green the following urine colours will not be detected or reported: orange, light brown, brown, dark brown, light red, dark red, other if the urine colour orange, light brown, brown, dark brown, light red, dark red or other colour than those listed as ‘can be detected and reported’ is visually observed during processing. the customers are recommended to take the following actions: consider reporting the visually observed colour reading using the user’s laboratory reporting system (e.G. hardcopy, lis). consider using an approved back-up analyzer to process and report these samples if the colours above are needed within the user’s laboratory. the manufacturer will update the ichemvelocity operator’s manual to reflect colours that can be detected and reported by cgm part numbers listed above. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 april 2017.

Device

iChemVELOCITY Urine Chemistry Systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Iris International iChemVELOCITY Urine Chemistry Systems
  • Manufacturer
    Iris International

Manufacturer

Iris International