Events

Alerte De Sécurité sur DiaMed Q.C. 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 Bio-Rad.

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
    2017-09-07
  • Date de publication de l'événement
    2017-09-07
  • 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_20170907.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: bio-rad diamed q.C. system medical device manufacturer, bio-rad, has issued a safety alert concerning its diamed q.C. system. the affected devices are identified as the following:- material number: 45950 lot number ihd: i) 45950 46 1 and ii) 45950 47 1 lot number sap: i) 166035461 and ii) 172383471 expiry date: i) 25 sep 2017 and ii) 9 oct 2017 the manufacturer has been made aware that samples of the product diamed q.C. system, ihd lot number 45950 46 1 and 45950 47 1, show excessive hemolysis in samples 1 and 4, and weakly in sample 2. tests have been performed internally and the manufacturer can confirm that currently a clear result is returned with manual testing and on the saxo- swing, ih-1000 with the hemolysed qc samples. with ih-500, users may observe uninterpretable results on reverse grouping. in this case, users should use another sample to perform the reverse grouping. [note: tests involving serum 1 and serum 2 are in no way affected.] according to the manufacturer, a risk assessment has been performed and no patient risk has been identified. users may continue to use the hemolysed cells as long as they give the expected results. the current situation has shown that the hemolysed lots will still allow the customers to perform qc testing for the following applications: typing abo/d and phenotype rh kell antibody screening and identification compatibility testing according to the local supplier, the affected products are not distributed in hong kong if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 september 2017.

Device

DiaMed Q.C. System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Bio-Rad DiaMed Q.C. System
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad