Events

Alerte De Sécurité sur PK7300 Automated Microplate System

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
    2017-06-27
  • Date de publication de l'événement
    2017-06-27
  • 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_20170628a.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 pk7300 automated microplate system medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its pk7300 automated microplate system. the manufacturer has confirmed that, during sample processing under certain conditions, the pk7300 does not always generate a reagent dispensing pressure error when the reagent vial becomes empty and no reagent is dispensed. sample processing will continue after a vial is empty only when the reagent alarm volume, limit volume and associated mode shift alarm have not been set. the above issue may lead to false negative test results with blood grouping reagents. results will not be generated for tests using cellular or particle reagents. wells without cellular or particle reagents will be flagged as empty (.E flags). the manufacturer advises users to take the following actions:- verify that the following are all set on all pk7300 analyzers in the laboratory: alarm volume and limit volume in the common test parameter -name (reagent tab) menu. either “to pause” or “to measure 2” is selected for “at short reagent volume alarm” on the mode shift tab in the system- system menu. if the parameters described above have not been set on all pk7300s in the laboratory, affected users should follow the instructions in the pk7300 user’s guide and the information provided by the manufacturer to set them. when users place the reagent vials in the reagent tray, they should make sure that each vial is fully seated to the bottom of the tray. the manufacturer will update the pk7300 user’s guide to include the information described in the actions above to indicate that the settings for the alarm volume, limit volume and associated mode shift are required. additionally, a statement will be added to insure that the reagent vials are fully seated to the bottom of the reagent tray. 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 27 june 2017.

Device

PK7300 Automated Microplate System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter PK7300 Automated Microplate System
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter