Events

Alerte De Sécurité sur Product Trade Name: CALCIO TITULOMETRICO. N. Anvisa Reg.: 10009010007

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 LABTEST DIAGNOSTICA SA.

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
    832
  • Date
    2006-05-05
  • 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
    Anvisa will continue to follow the case, in order to ensure that health products marketed in Brazil have the safety and efficacy necessary for the good performance of the product.
  • Cause
    Labtest diagnóstica sa is initiating recall of batches 4051 // 4052 // 5053 // 5054 // 6001 of the titulometric calcium product, due to having verified that these batches show a quality deviation, manifesting results with total error higher than minimum specification based on the components of the biological variation. the analyzes carried out with the aforementioned lots of titulometric calcium lead to high values ​​in the determination of calcium in the samples. the occurrence was confirmed after investigation of a customer complaint. the results with increased false positives may trigger a process of clinical investigation of the cause of hypercalcemia, increasing the demand for complementary diagnostic tests. according to company information, the identified quality deviation does not cause adverse effect to the patients, that is, does not produce, real or potentially, results that affect the safety of those. lots affected: • 4051 (validity 09/2006) • 4052 (validity 12/2006) • 5053 (validity 05/2007) • 5054 (validity 09/2007) • 6001 (validity 03/2008).
  • Action
    - LABTEST DIAGNOSTICA SA notified Anvisa of the incident; -A LABTEST DIAGNOSTICA SA informed its distributors / customers of the occurrence, through a press release, and started the process of collecting the market, both the units sold and those that were in its stock and those of its distributors. The company will be replacing the kits at no additional cost to the customer; - LABTEST provided the SAC - DDG 0800 313411; - LABTEST is implementing corrective actions to remove the cause of quality deviation, such as employee retraining of the EDTA raw material evaluation and substitution method in the Cat. 33.3 component.

Device

Product Trade Name: CALCIO TITULOMETRICO. N. Anvisa Reg.: 10009010007

Manufacturer

LABTEST DIAGNOSTICA SA
  • Source
    ANVSANVISA