Events

Alerte De Sécurité sur IMx HIV-1 HIV-2 III Plus Reagents (List No. 8C98-20). IMx HIV-1 HIV-2 III Plus Controls (List No. 8C98-12). Westen Blot HIV Blot 2.2 (List # 2F02-01 and 8E02-01)

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
    527
  • Date
    2002-03-19
  • 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
    Brazil - 03/14/2002, the company informs that it has followed the program of product collection, through verbal communication measures to all customers, started on January 28, 2002; Formal communication initiated on 01.02.2002, sent to clients; correspondence sent to distributors. Products Collected: Western Blot HIV Blot 2.2 - No. 2F02-01, lots # AE0087, AE0088, AE0098, AE0100. AE0101 and AE1006. Western Blot HIV Blot 2.2 - List # 8E02-01 - Lots numbers: AE1021, AE0102, AE0096, AE1001, AE1008, AE1011, AE1017, AE1024, AE1031 and ae1034. IMx HIV-1 HIV-2 III Plus Reagents (List No. 8C98-20) - Lots numbers: 78172LU03, 80180LU01, 80180LU03, 80180LU04 and 81246lU03. IMx HIV-1 HIV-2 III Plus Controls (List No. 8C98-12) - Lots numbers: 76085HP00 and 80346HP00.
  • Cause
    Unsatisfactory for internal labels and instruction manual, for not presenting information in portuguese according to bulletin of analysis nº 4157.00 / 01, nº 4158.00 / 01, n ° 4159.00 / 01 and 4160.00 / 01 of the incqs.
  • Action
    The Technical Board of the Sanitary Surveillance Center of the State Health Secretariat SÃO PAULO, through CVS 27/02 - GT 4 DITEP, notified that the results of the analysis of these products revealed unsatisfactory. It determined the prohibition of marketing and use of all the units of the batch of the product in question, collection by the undertaking of all units of the batch marketed and other supplies under the same conditions; presentation by the company of the report on the payment made to the local VISA; that the establishments acquiring the products of the said company make due notification to corresponding regional VISA for complementary measures.

Device

IMx HIV-1 HIV-2 III Plus Reagents (List No. 8C98-20). IMx HIV-1 HIV-2 III Plus Controls (List No....

Manufacturer

ABBOTT LABORATORIOS DO BRASIL LTDA.
  • Source
    ANVSANVISA