Events

Alerte De Sécurité sur Technical Name: TECHNO - ANVISA registration number: 80004040145. Risk class: II - Affected model: 009895 - Affected lots: 212; 318; 375; 377; 490; 492; 493; 497; 507; 541; 545; 1017; 1018; 1026; 1049; 1050; 1064; 1065; 1066; 1080; 1084; D0104; D0197 (see Distribution Map IN ANNEX)

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 DIAMED LATINO AMÉRICA S.A.; DIAMED GMBH.

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
    1770
  • Date
    2015-12-15
  • 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
    Customers who do not use Techno for Lu (a) E Lu (b) antigens (Lutheran Antigens) are not subject to the risk of reading incorrect results.
  • Cause
    Adverse reactions weaker than the expected may be observed for antigens lu (a) e lu (b) (antigens lutheran) when tested in the bio-rad techno equipment in internal batteries better than 24 samples, for what a long period of dispensation is necessary.
  • Action
    a) Risk classification according to notification form: III (Situation in which there is a low probability that the use or exposure to a health product may have adverse health consequences // b) Classification of the field action: UPDATE, CORRECTION OR COMPLEMENTATION OF THE INSTRUCTIONS FOR USE // c) Field action code: AC 2015/03 // d) Recommendations to users and patients: WE RECOMMEND THAT CUSTOMERS FOLLOW THE FOLLOWING INTRUTIONS WHEN THE ANTIGENS LUTHERAN WERE TESTED:. TEST NUMBER: PR45A [PRODUCT NAME: ANTIGEN: ANTI-LUNE / Lub (5123)] PRODUCT CODE: 006031 (ID CARD IDENTIFICATION ID NO: 51230) LIMITED BATTERY SAMPLE QUANTITY BY TECHNO: 24 SAMPLES / BATTERY , TESTED ONLY FOR THIS TEST CODE, (ii). TEST NUMBER: PR44H [TEST NAME: ANTIGEN: ANTI-LAMINE (5031)] PRODUCT CODE: 007351 (ID CARD IDENTIFICATION ID NO: 50310) LIMITATION OF BATTERY SAMPLES BY TECHNO: 24 SAMPLES / BATTERY - NOTE : CAN BE TESTED ON THE SAME BATTERY WITH THE PR44I TEST; (iii). LIMITATION OF SAMPLE QUANTITY BY BATTERY ON TECHNO: 24 SAMPLES / BATTERY - NOTE: This product has been tested and found to comply with the limits for a Class B digital device, : CAN BE TESTED ON THE SAME BATTERY WITH THE PR44H TEST; (iv). FOR TESTING: PR42A [TEST NAME: ANTIGENIC PROFILE: P1-Lea-Leb-Lua-Lub-ctl (5037)] PRODUCT CODE: 008510 (ID CARD ID NO: 50371) LIMITATION OF BATTERY SAMPLE QUANTITY NO TECHNO: 24 SAMPLES / BATTERY - NOTE: CAN BE TESTED ON THE SAME BATTERY WITH THE PR41A // TEST (SEE NOTICE TO CUSTOMERS AND NOTIFICATION SCREEN)

Device

Technical Name: TECHNO - ANVISA registration number: 80004040145. Risk class: II - Affected model...

Manufacturer

DIAMED LATINO AMÉRICA S.A.; DIAMED GMBH