Events

Alerte De Sécurité sur IMMAGE Immunochemistry Systems Cuvette Sectors

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

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
    2017-03-01
  • Date de publication de l'événement
    2017-03-01
  • 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_20170301.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: beckman coulter immage immunochemistry systems cuvette sectors medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its immage immunochemistry systems cuvette sectors [part number (p/n): 470706; all lot]. the manufacturer has determined that immage cuvette sectors (p/n 470706) may be missing one of two positioning pins. cuvette sectors missing a positioning pin can become misaligned. if a cuvette sector becomes misaligned, under rare circumstances, the instrument mixer paddle may rub against the inside wall of the cuvette and create a noise. the manufacturer has no evidence of erroneous results being generated due to this issue to date. the manufacturer is instructing affected users to take the following actions:- inspect the cuvette sectors on the instrument reaction wheel to determine if any are missing positioning pins. replace any cuvette sectors with missing pins. upon completion of inspection, confirm that all cuvette sectors are seated in the reaction carousel. inspect the spare parts inventory of cuvette sectors to determine if any are missing positioning pins. discard any cuvette sector with missing positioning pin. a retrospective review of results is not necessary. 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 01 march 2017.

Device

IMMAGE Immunochemistry Systems Cuvette Sectors
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter IMMAGE Immunochemistry Systems Cuvette Sectors
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter