Events

Alerte De Sécurité sur LYSERCELL Technical Name: LISE SOLUTION FOR HEMATOLOGY ANVISA Registration Number: 80015490091 Hazard Class: I Affected Model: LYSERCELL WDF - 5L Serial Numbers Affected: P6006 - SINGLE LOT WITH THE ABOVE PROBLEM

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 SYSMEX DO BRASIL INDÚSTRIA E COMÉRCIO LTDA.; SYSMEX DO BRASIL INDÚSTRIA E COMÉRCIO 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
    2177
  • Date
    2016-12-14
  • 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
    THE CUSTOMERS WHO PURCHASED THIS PRODUCT LOT WERE CONTACTED THROUGH E-MAIL AND POSSIBLE TELEPHONE CONNECTION, WHICH EXPLAINED THE USE OF THE LOTS ACQUIRED, WHICH CONSISTS OF THE COMPLETE DISCARACTERIZATION OF THE HEALTH PRODUCT; BEYOND REFUND OF PRODUCTS. THE CLIENTS WERE INFORMED THAT THE USE OF THE PRODUCT DOES NOT INTERFERE IN THE QUALITY AND QUANTITY OF THE DIAGNOSTIC TESTS, AND THAT SUCH STATUS OF DISPOSAL OF PRODUCTS APPLIES FOR PRIMAR FOR THE LEGITIMACY OF THE SYMPTOM CRYPTOGRAPHY SEAL; IN ADDITION TO AVOIDING THE DIFFICULTY OF USING THE NEW UNIT WITH THE SAME CODE. LETTER OF COMMUNICATION WITH THE RECOMMENDATIONS TO THE CUSTOMER IN ANNEX.
  • Cause
    The lysercell-wdf product is an in vitro diagnostic reagent, used in cell screening instruments. the reagent has on its label a crypttography code, which is a mechanism that against fake. the potential package p6006 has a replication of printing of the crypttographic codes and if it is performed to replace a new unit of reagent with the code replaced, of the same package p6006, this exchange will not be identified by the instrument. the print failure does not influence the final quality of the product or the diagnostic test.
  • Action
    Field Action Code RC0115 triggered under the responsibility of the company SYSMEX DO BRASIL INDÚSTRIA E COMÉRCIO LTDA.

Device

LYSERCELL Technical Name: LISE SOLUTION FOR HEMATOLOGY ANVISA Registration Number: 80015490091 Ha...

Manufacturer

SYSMEX DO BRASIL INDÚSTRIA E COMÉRCIO LTDA.; SYSMEX DO BRASIL INDÚSTRIA E COMÉRCIO LTDA.