Events

Alerte De Sécurité sur Premier Buffer B Reagent

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

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
    2017-06-07
  • Date de publication de l'événement
    2017-06-07
  • 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_20170607a.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: trinity biotech premier buffer b reagent medical device manufacturer, trinity biotech, has issued a medical device safety alert concerning its premier buffer b reagent [product code: 01-03-0096 (940 ml); lot number: 6524]. the manufacturer has identified that the closed bottle stability for some bottles of lot 6524 may be reduced due to a broken seal under the cap of unopened bottles. in cases where a broken seal of an unopened bottle is encountered, the open bottle stability is essentially started and the bottle stability performance will be reduced, as it would over time when installed on the premier hb9210 system. where analytical run qc recovery is within range, the performance of the system and results are acceptable. however, if an unopened reagent bottle is found to have a broken seal prior to use, the open bottle stability has started. prior to consumption of the bottle, it may be observed that controls drift out quicker than normal, thereby requiring more frequent calibrations. the qc recovery (controls) verification will identify and contain this issue, as designed and there is no need for review of previously reported results. a thorough investigation into the root cause has been conducted and no other lots are affected. to avoid need for extra control runs and calibrations, the manufacturer recommends: discontinue the use of the above reagent lots. destroy any remaining product. notify all end-users of this notification. product replacement is on-going. 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 7 june 2017.

Device

Premier Buffer B Reagent
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Trinity Biotech Premier Buffer B Reagent
  • Manufacturer
    Trinity Biotech

Manufacturer

Trinity Biotech