Events

Alerte De Sécurité sur pts panels chol+glu test strips

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

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
    2018-03-19
  • Date de publication de l'événement
    2018-03-19
  • 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_20180319b.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: pts diagnostics pts panels chol+glu test strips medical device manufacturer, pts diagnostics, has issued a medical device safety alert concerning its pts panels chol+glu test strips [lot numbers: a705 and a707]. based on the results of the manufacturer’s internal testing, there is potential for under-recovery of the glucose analyte, and therefore, potential for lower glucose test results. according to the manufacturer, the affected lots were shipped during the timeframe of april 19 to june 2, 2017. the correction is being conducted due to potential for loss of activity of the glucose analyte prior to the full stated shelf life (august 2018). the manufacturer has decided to remove remaining product from the market. the affected customers are requested to take the following actions: immediately check their inventories and, if they have further distributed this product, identify the users and notify them at once of this product recall. any materials from the affected lot numbers that are at their facility and/or their users’ facilities should be immediately segregated and destroyed in such a manner as to prevent further use. according to the manufacturer, the affected lot a705 is distributed in hong kong. if you are in possession of any affected units, please contact your supplier for necessary actions. posted on 19 march 2018.

Device

pts panels chol+glu test strips
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: PTS Diagnostics PTS Panels CHOL+GLU test strips
  • Manufacturer
    PTS Diagnostics

Manufacturer

PTS Diagnostics