Events

Alerte De Sécurité sur ZYM B, registration number 10158120560, hazard class I, lots: 1003765610, 1003772410, 1003772470, 1003787970, 1003790030, 1004077210, 1004097610, 1004355410, 1004355730.

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 Brasil SA.; Biomérieux 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
    1798
  • Date
    2015-01-15
  • 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
    According to the company, a corrective action plan was initiated to define the root cause and determine the long-term action plan to resolve the non-compliance. As a result of the ZYM B performance change, the reported risk is potentially a negative result of some API tests, misidentification of some species with API 20 Strep, NH API, Listeria API and Coryne API. Staph API is not affected by a risk of misidentification. As for ZYM API, since it was designed to search for enzymatic activities, there is no risk of error of identification of microorganisms. The simulation was done with the API databases of each gallery API involved, in order to understand the impact of a negative result of these tests on the final identification result. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client and destination of the nonconforming products.
  • Cause
    Discrepancies in identification related to identification galleries api. these discrepant identification results are due to false negative results in gallon tests revealed by the use of zym b reagent. the investigation confirmed a loss of performance due to light exposure after 3 months of life for zym b api, which could lead to to false negative results from biochemical tests using zym b reagent in all api galleries quoted below: strep api 20, coryne api, staph api, zym api, nh api, listeria api.
  • Action
    Letter of Letter to the Client. Action Code: FSCA 2752. Forwarded LETTER to customers, requesting that they distribute the information to all appropriate personnel in the laboratory, keeping a copy in their files, and transmitting this information to all parties who may use this product. The company informs customers that they will continue to use the ZYM B kits that are still in stock with a mandatory requirement before using a ZYM B ampoule, and each day of using the API galleries: conduct quality control with the ATCC strains , as described in each package of API galleries involved and as described in the Letter to Customers (see annex). In addition, it is necessary to protect the ZYM B light exposure kit as described in the package insert. ////// The company is working on a long-term solution to improve the robustness of the ZYM B reagent. A note will be added on the future packaging of ZYM B to explain the required actions required in the letter to the customer.

Device

ZYM B, registration number 10158120560, hazard class I, lots: 1003765610, 1003772410, 1003772470,...

Manufacturer

Biomerieux Brasil SA.; Biomérieux S.A.