Alerte De Sécurité sur IMMUNOCARD TEST KITS OF HELICOBACTERIA PILORI. IDENTIFIERS: PRODUCTS NO.S 710030; LOTS NOS .: 710030.093 EXP FEB 20 2002, 710030.095 EXP MAR 8 2001, 710030.096 EXP MAR 8 2001, 710030.097 EXP MAR 6 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 MERIDIAN DIAGNOSTICS INC.

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
    148
  • Date
    2000-09-27
  • 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
    Test ports of the kits mentioned may indicate false-negative results. the manufacturer started a removal by correspondence, phone and fax on august 23, 2000.
  • Action
    MAKE SURE THAT YOU HAVE BEEN RECEIVED AND RECEIVED THE MERIDIAN DIAGNOSTICS KNOWLEDGE FORM. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. MERIDIAN DIAGNOSTICS AFFIRMS THAT USERS SHOULD DISCONTINUE THE USE OF THESE KITS AND DISCARD THEM. MERIDIAN DIAGNOSTICS ALSO AFFIRMS THAT KIT DISTRIBUTORS SHOULD DISCONTINUE THEIR DISTRIBUTION, NOTIFY REMOVAL CONSUMERS AND PROVIDE A COPY OF THE KNOWLEDGE FORM. FILL IN THE KNOWLEDGE FORM AND FAX FOR MERIDIAN DIAGNOSTICS NO 1 (513) 272-5432. MERIDIAN DIAGNOSTICS WILL REPLACE ANY PRODUCT AFFECTED BY A REPLACEMENT KIT, WITHOUT ADDITIONAL COSTS. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH THE MERIDIAN DIAGNOSTICS TECHNICAL SUPPORT DEPARTMENT BY PHONE 1 (513) 271-3700 IN THE UNITED STATES

Manufacturer

  • Source
    ANVSANVISA