Events

Alerte De Sécurité sur EliA CCP Well, EliA CCP Well, EliA CCP Well, EliA CCP Well, EliA IgG Conjugate, EliA IgG Conjugate 50, EliA IgG Conjugate 200, EliA CCP Positive Control 250, EliA CCP Positive Control 100 Conjugate 200, EliA CCP Positive Control 250, EliA CCP Positive Control 100 ANVISA Registration Number: 80254180068 Hazard Class: II Model Affected: 14-5515-01 (80254180068); 83-1005-01 (80254180059); 83-1017-01 (80254180067); 83-1018-01 (80254180128); 83-1035-01 (80254180113); 83-1040-01 (80254180116)

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 Phadia Diagnosticos Ltda.; Phadia AB.

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
    2192
  • Date
    2016-10-21
  • 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
    Use the listed ranges set for EliA CCP Positive Control (83-1040-01 and 83-1035-01) when used in combination with listed batches of the indicated batches of EliA IgG Conjugate (83-1017-01, 83-1005 -01 or 83-1018-01). Do not use lots (14-5515-01 kit lot starting with 0200) from the new EliA CCP Well with lots of the EliA IgG Conjugates Antiquity listed in the Notice. Do not use lots (14-5515-01 kit lot starting with 0200) from the new EliA CCP Well with lots of EliA CCP positive controls listed in the Notification. Fill in the EliA CCP Positive Control Field Action Confirmation form on the notification and return to the record holder.
  • Cause
    The investigation of complaints received concluded that when elia ccp well (14-5515-01) is used in combination with the elia igg conjugate (83-1017-01, 83-1005-01 or 83-1018-01), the results of anti-ccp can be elevated. the positive trend of the elia ccp test will change a small percentage of test results from negative to indeterminate and from undetermined or negative high to low positive. tests on clinical serum samples from patients with confirmed rheumatoid arthritis (ra), serum from healthy blood donors and other disease controls resulted in <1% of the samples having changed from negative to positive, according to the current ranges of values ​​(the total study included 472 samples). the results of the evaluation study performed confirmed the variance within the current clinical performance, and it was concluded that the clinical impact of the observed trend can be neglected.
  • Action
    Field Action FSN Code 2016-02 triggered under the responsibility of the company PHADIA DIAGNOSTICOS LTDA. Company will guide the combination of lots of EliA CCP test

Device

EliA CCP Well, EliA CCP Well, EliA CCP Well, EliA CCP Well, EliA IgG Conjugate, EliA IgG Conjugat...

Manufacturer

Phadia Diagnosticos Ltda.; Phadia AB