Events

Alerte De Sécurité sur CIDEX OPA Solution 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 Advanced Sterilization Products.

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
    2015-04-08
  • Date de publication de l'événement
    2015-04-08
  • 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_20150409.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: advanced sterilization products cidex opa solution test strips medical device manufacturer, advanced sterilization products, has issued a medical device safety alert concerning its cidex opa solution test strips the manufacturer has determined that shelf life data for the cidex opa solution test strips is effective for only 10 months of the test strip’s labeled 12-month shelf life. according to the manufacturer, there is no potential risk to patient safety, as test strips used at the end of shelf life would indicate a false negative (e.G. “fail” result for solution above the minimum effective concentration). this issue could be observed during either qc testing of the test strips prior to use (in accordance with the instructions for use) or during testing of cidex opa solution when the test strips are near the end of shelf life. there was no evidence that a false positive (e.G. a “pass” result for solutions below the mec) would occur. a corrective action is in place to update the shelf life of the cidex opa solution test strips from 12 months to 10 months. the manufacturer advises users to check the expiration date on all affected products. affected users are also advised to update the expiry date from 12 to 10 months. 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 8 april 2015.

Device

CIDEX OPA Solution Test Strips
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Advanced Sterilization Products CIDEX OPA Solution Test Strips
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products