Alerte De Sécurité sur Reagents, immunoassay, control, toxicology ,. Controls Multiconstituent X Systems for Drug Testing Addition of List Number: 09687-12; Number of lots: 72409M100 EXP OCT 31 2001, 74338M300 EXP NOV 30 2001

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 Abbott Laboratories.

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
    340
  • Date
    2001-11-16
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    The methadone concentrations of the above kits were manufactured at methadone concentrations below the target value. this may result in out-of-range control values ​​inserted into the kit when tested with adx, tdx / tdxflx or axsym methadone reagents. the manufacturer states that no other analyzer in the above kits has been affected.
  • Action
    Please verify receipt of the product recall letter dated June 14, 2001 from Abbott Laboratories. Identify and isolate all affected products in your inventory. Please retain and attach the product correction letter including Annexes I and II describing the new limits for batches of the above methadone components for your laboratory records. Reestablish the limits of variation of laboratory controls for the above methadone components based on the charts provided in the charts sent by Abbott Laboratories. If you have shipped this product to other laboratories, Abbott requests that you inform the units of this removal. For more information, please contact your local representative. ANVISA is interested in following if there has been good collaboration of the manufacturer | your laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.

Manufacturer

  • Source
    ANVSANVISA