Events

Alerte De Sécurité sur ACCESS THYROGLOBULIN CALIBRATORS, Registration No. 10033120496, Lots 325451, 327168 and 330203

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 BECKMAN COULTER DO BRASIL COM. E IMP. DE PROD. DE LAB. 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
    1367
  • Date
    2014-02-24
  • 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
    This problem can result in high patient and quality control results. The false control results and the patient's thyroglobulin may lead to an additional test. Based on the internal test, the observed increase in results ranged from 11% to 18% when the calibrators were reconstituted with 2.0 mL of distilled water and allowed to stand for 30 minutes prior to use. All levels of control and patient outcomes were affected. The percentage increase in response observed depends on the reconstitution time before use for the affected lots. A reconstitution time of 1 hour and 40 minutes or more using the affected batches provided appropriate recovery of control and patient outcomes. ///// UPDATE - 4/3/2014 - The company forwarded a response letter to all customers who received the aforementioned lots informing them of the necessary actions and forwarded an uncommitted lot. If any service still has lots quoted in this alert, please contact the company.
  • Cause
    Beckman coulter of brazil received beckman coulter inc., an important product notice stating that the 30 minute reconstitution time is inadequate to fully reconstitute batches 324753, 325451, 327168 and 330203 of the access thyroglobulin calibrator.
  • Action
    The company directs customers to: i- Discard all Access Thyroglobulin Calibrator kits listed above. Determine when batches of calibrator number 324753, 325451, 327168, and 330203 were calibrated in your system and evaluate all results generated with the Access Thyroglobulin Calibrator to determine if the control and / or patient results were higher than expected or did not match the patient's clinical status. iii - Under the direction of the Laboratory Director, notify physicians that it is possible that the thyroglobulin sample results reported by your laboratory are affected by this problem.

Device

ACCESS THYROGLOBULIN CALIBRATORS, Registration No. 10033120496, Lots 325451, 327168 and 330203

Manufacturer

BECKMAN COULTER DO BRASIL COM. E IMP. DE PROD. DE LAB. LTDA