Events

Alerte De Sécurité sur IMX TACROLIMUS II CALIBRATORS no. 3C10-01, Lot no. 94164M100, Anvisa Registry nº 10055310710

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 LABORATORIOS DO BRASIL LTDA.

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
    757
  • Date
    2003-11-25
  • 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
    Recommendations: 1 - Identify if the product IMX TACROLIMUS II CALIBRATORS no. 3C10-01, Lot no. 94164M100, Anvisa Registry nº 10055310710 is in use or in stock. 2 - Discontinue use of the IMX TACROLIMUS II CALIBRATORS no. 3C10-01, Lot no. 94164M100, Anvisa Registry no. 10055310710. Store this material in your laboratory for later return to Abbott Laboratories - Diagnostics Division. 3 - Fill in the Response Protocol and send to fax 0xx11 - 5536 7181, for the subsequent return of the product. The company will collect the material and provide a refund. If you have any further questions or concerns, please contact the Customer Service Center at 0800 119099, or contact your local representative.
  • Cause
    The product imx tacrolimus ii calibrators no. 3c10-01, lot no. 94164m100 may present instability of the calibrators during the calibration of the imx tacrolimus reagents test, generating the following messages on the imx instrument: code 157: check 1 out of range, code 159: check 3 out of range and code 161: check 5 out of range.
  • Action
    The Abbott Laboratories-Diagnostics Division has reviewed the available data and concludes that: The use of the IMX TACROLIMUS II CALIBRATORS no. 3C10-01, Batch No. 94164M100 may generate an increase in calibration error codes when using a few batches of the reagent IMX TACROLIMUS II Reagents (list no. 3C10-20). Results of patients who were refueled with the valid calibration curve and test control values ​​within the expected range were not affected and are considered valid. The Abbott Laboratories-Division Diagnostics is conducting research to determine the cause of this instability.

Device

IMX TACROLIMUS II CALIBRATORS no. 3C10-01, Lot no. 94164M100, Anvisa Registry nº 10055310710

Manufacturer

ABBOTT LABORATORIOS DO BRASIL LTDA
  • Source
    ANVSANVISA