Alerte De Sécurité sur Bioline HIV and Malaria rapid test kits

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
  • Date de publication de l'événement
  • 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
    Medical device safety alert:standard diagnostics bioline hiv and malaria rapid test kits the world health organization (who) has issued a notice of concern on the following products manufactured by standard diagnostics, inc. sd bioline hiv ag/ab combo sd biolime hiv-1/2 3.0 sd bioline malaria ag p.F/pan sd bioline malaria ag p.F an inspection of manufacturing of the above mentioned products was conducted by the who prequalification of diagnostics programme from 28 september to 1 october 2010 at the hagal-clong giheung-gu site of standard diagnostics. on the 3 november 2010, standard diagnostics received the who final inspection report for this first inspection that contained a significant number of nonconformities but did not include critical nonconformities. a re-inspection of the hagal-dong giheung-gu site and an inspection of the newly acquired bora-dong giheung-gu site took place on 6-9 march 2012. the inspection team found that the manufacturer had not effectively implemented rectification of the requirements according to their action plan from the first inspection. the re-inspection revealed a significant number of major and critical nonconformities. there were 5 critical nonconformities detected: lack of adequate document control. misleading information presented to the who inspection team. production processes were not sufficiently under control, not qa driven and not independent of production. lack of precise identification and traceability throughout production processes. lack of adequate quality control over in process and release of test kits. according to who, the effectiveness of the quality management system at standard diagnostics, inc. had deteriorated since the first who inspection and requires considerable rectification before confidence in the quality of the products being produced by standard diagnostics, inc. is re-established. who will withhold prequalification of all active applications for products manufactured at the above mentioned sites, and close any other applications received. this will remain in effect until these nonconformities have been satisfactorily addressed and who has verified and confirmed the acceptability of the corrective actions. for sd bioline hiv-1/2 3.0, it will not be eligible for procurement by who until further notice. if you are in possession of the products, please contact your supplier for necessary actions. posted on 10 july 2012.


  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Standard Diagnostics Bioline HIV and Malaria rapid test kits
  • 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