Events

Alerte De Sécurité sur microscan synergies plus and microscan rapid/s plus negative panels

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Siemens Healthcare 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
    2013-09-05
  • Date de publication de l'événement
    2013-09-05
  • 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_20130905.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: siemens microscan synergies plus and microscan rapid/s plus negative panels the united states food and drug administration (fda) has issued a medical device safety alert concerning microscan synergies plus and microscan rapid/s plus negative panels, manufactured by siemens healthcare diagnostics, inc. the affected products are identified as follows:- synergies plus negative urine combo 1- 10444745 / b1025-106 synergies plus negative combo 2 - 10444747 / b1025-108 synergies plus negative breakpoint combo 7 - 10444748 / b1025-109 synergies plus negative urine combo 2 - 10444749 / b1025-112 synergies plus negative urine combo 5 - 10483101 / b1025-115 microscan synergies plus and microscan rapid/s plus negative panels are reporting false susceptible and false intermediate results for imipenem and meropenem antimicrobial susceptibility testing when using the microscan walkaway system. this defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy. this recall covers 78,020 panels distributed in the us between 07/11/2011 and 08/02/2013. according to the fda, the manufacturer has sent an urgent field safety notice dated 21 august 2013, to all affected customers. the letter identified the defective products, problem and actions to be taken and also instructed customers to suppress all reporting of sensitive and intermediate results for imipenem and meropenem. in addition, siemens recommends that customers consider the need to review previous test results, conduct patient follow-up, and/or repeat testing. for details, please visit the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm367217.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm367163.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 september 2013.

Device

microscan synergies plus and microscan rapid/s plus negative panels

Manufacturer

Siemens Healthcare Diagnostics