Events

Alerte De Sécurité sur Automate 2550 and 1250, Aliquotter Tip Present Sensor

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
    2018-01-31
  • Date de publication de l'événement
    2018-01-31
  • 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_20180131b.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 automate 2550 and 1250, aliquotter tip present sensor medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its automate 2550 and 1250, aliquotter tip present sensor. the manufacturer has identified a rare potential issue with the tip present sensor within the robot of the aliquoter module. there has been one report of a misaligned sensor in an automate system, which resulted in the system processing samples without pipette tips. a small number of samples were subject to cross-contamination and were sent to the error rack prior to analysis. in this particular case, the system gave no external sign of a misaligned tip present sensor. according to the manufacturer, there is no impact to the sorter module associated with this issue. in the remote instance that a sensor is misaligned, and the system does not trigger the error message that a tip is not present, there is a remote chance of sample cross-contamination. as a precautionary measure, the manufacturer has instructed field service engineers to inspect the tip present sensor for misalignment at their next service visit. if the users suspect or observe unusual contamination of the tip carrier arm while performing daily maintenance, as described in the instructions for use, they are recommended to contact the local supplier and discontinue use of the aliquotter module. 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 31 january 2018.

Device

Automate 2550 and 1250, Aliquotter Tip Present Sensor
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter Automate 2550 and 1250, Aliquotter Tip Present Sensor
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter