Events

Alerte De Sécurité sur BioConcept RESIST-3 O.K.N. K-set

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

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
    2017-02-15
  • Date de publication de l'événement
    2017-02-15
  • 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_20170215a.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: coris bioconcept resist-3 o.K.N. k-set medical device manufacturer, coris bioconcept, has issued a field safety notice concerning its resist-3 o.K.N. k-set [product code: sun-1kr5; model (lot number): cassette (1kr5k1618); catalogue number: k-15r5; manufacturing date: 12 dec 2016; expiry date: 17 may 2017]. according to the manufacturer, there is a slight shift between the test lines oxa-48 (o) and kpc (k) of the strip and the labeled inscription on the cassette. both test lines of strip are slightly lower than the letter ‘o’ and ‘k’ labeled on the cassette. the problem has been detected by a collaborative contact during some laboratory tests. there is a potential risk of confusing the kpc line with the oxa-48 line when only the kpc signal is readable after the test. a wrong interpretation could impact the treatment received by the patient. the performance of the test is not altered at all and the affected lot meets the manufacturer’s quality standards. to facilitate interpretation of the result, it is recommended to indicate the position of the kpc green line before starting the test. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 15 february 2017.

Device

BioConcept RESIST-3 O.K.N. K-set
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Coris BioConcept RESIST-3 O.K.N. K-set
  • Manufacturer
    Coris BioConcept

Manufacturer

Coris BioConcept