Alerte De Sécurité sur SD Bioline HIV-1/2 v3.0

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Standard 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
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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
    Field safety notice: sd bioline hiv-1/2 v3.0 the world health organization (who) issued a field safety notice on 16 nov 2011 concerning sd bioline hiv-1/2 v3.0 manufactured by standard diagnostics, inc. according to the notice, some lots of the device showed unacceptably high rate (around 50%) of invalid test results. subsequently, who issued an information update on 6 jan 2012 stating that the devices giving invalid test results show a substantial red background in the test window where results are read. this blurs the visibility of the test lines and therefore makes correct interpretation of the test result impossible. this means that no test result can be given, rendering the test invalid. standard diagnostics has conducted a root cause analysis as recommended by the who and determined the problem was due to defective sample pad and non-standard shape of nozzle leading to excessive assay diluents migration which would blur the test window where results are read. according to who, there is no evidence that would warrant the retesting of individuals for whom an unambiguous, valid positive or negative test result using this test, has been obtained. a positive hiv test result given to an individual should always be confirmed with a second and/or third test different from the initial screening test. persons whose test results were invalid (non-readable) would need to be retested as their serostatus remain undetermined. who recommended that national authorities should discontinue use of all affected lots of the product and quarantining also the unaffected lots until further testing can determine their performance. further, who also recommended any pending procurement of the product should be cancelled, and no new procurement initiated until further notice. who will re-inspect the manufacturing site and an information update will be issued afterwards. according to the local supplier, affected lots have not been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.


  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: SD Bioline HIV-1/2 v3.0
  • Manufacturer


  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source