Events

Alerte De Sécurité sur ZYM B / API NH / API LISTERIA - Anvisa Record nº 10158120560 / 10158120563/10158120563, respectively

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par BIOMERIEUX S.A.

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
  • ID de l'événement
    1347
  • Date
    2014-01-07
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    The potential risk associated with the reported problem is an error of identification of microorganisms with API 20 Strep, NH API, Listeria API, Coryne API. ● Listeria API (Ref. 10300): Only one species can give a false identification: Listeria innocua will be identified as Listeria monocytogenes. The identification of Listeria monocytogenes is not impacted by the activity of ZYM B. ● Thirteen species may give a false identification and are: Alloiococcus otitis, Enterococcus avium, Enterococcus durans, Enterococcus faecalis, Enterococcus facium, Enterococcus Streptococcus spp., Streptococcus agalactiae, Streptococcus angiosus, Streptococcus dys.ssp dysagalactiae, Streptococcus dys.ssp equisimilis, Streptococcus pyogenes, Streptococcus salivarius ● Coryne API (Ref. 20900): Five species may give a false identification and are: Actinomyces radingae, Arcanobacterium bernardiae, Corynebacterium bovis, Dermabacter hominis, Microbacterium sp / aquatic Leifsonia. ● NH API (Ref. 10400): Two species may give a false identification and are: Neisseria gonorrhoeae and Neisseria meningitidis. A simulation using false negative results for this test has been performed with the database of API kits specific to each test. The investigations concluded that this could lead to an error in identifying some species with API 20 Strep, NH API, Listeria API and CoRyne API. The Staph API is not affected. There is no risk of error identification with Staph API and ZYM API (ZYM API is designed for the investigation of enzymatic activities, the same does not allow to identify microorganisms).
  • Cause
    During the quality control of a new batch of fb reagent, a visual defect was verified by biomérieux, which defect is linked to a batch of raw material which is also used in zym b reagent (reference 70493), which is used as a supplemental testing for results in some miniaturized biochemical tests including: • api 20 strep (20600), • coryne api (20900), • staph api (20500), and • zym api (25200). zym b reagent is also included in the following kits: api nh (10400) and api listeria (10300). investigations conducted by our quality assurance laboratory have confirmed a problem in the activity of the zym b reagent, whatever the color of the ampoule of the reagent zym b (whether a result is acceptable or not). this activity in question leads to a false negative result of some biochemical api tests using the reagent zym b. in fact, investigations are still underway in order to identify the root cause. a simulation using false negative results for this test has been performed with the database of api kits specific to each test. the investigations concluded that this could lead to an error in identifying some species with api 20 strep, nh api, listeria api and coryne api. the staph api is not affected. there is no risk of error identification with staph api and zym api (zym api is designed for the investigation of enzymatic activities, the same does not allow to identify microorganisms).
  • Action
    As a forwarded action Letter to all customers who purchased the affected products and lots, with detailed guidance on how to proceed with each product covered by this Field Action. access letter to the clients: http://portal.anvisa.gov.br/wps/wcm/connect/c9edee004282124e9100d57deea1c857/Communica+Biomerieux.pdf?MOD=AJPERES

Device

ZYM B / API NH / API LISTERIA - Anvisa Record nº 10158120560 / 10158120563/10158120563, respectively

Manufacturer

BIOMERIEUX S.A