Events

Safety Alert for Trade name: ID-DIAPANEL P Technical name: IMMUNOHEMATOLOGY - ENZYME HEMACY / HEMATELIC REAGENTS Registration number ANVISA: 80004040131 Hazard class: IV Model affected: 004214V Serial numbers affected: 45171.88.1

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by DiaMed Latino América S.A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2195
  • Date
    2017-02-08
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    * We recommend to immediately stop the use ONLY of test cells 1 of the kit "ID-DiaPanel-P", lot 45171.88.1 and "ID-DiaPanel", lot 45161.88.1. The other test cells (test red cells 2 to 11) are in compliance with the Quality Control criteria and should be used normally. * Identify and segregate boxes of products containing ONLY the test cells 1 of the "ID-DiaPanel-P" kit, lot 45171.88.1 and "ID-DiaPanel", lot 45161.88.1, to be returned to Bio-Rad. * Use the new test cells 1 (ID-DiaPanel-P 1, lot 05361.88.2 and ID-DiaPanel 1, lot 06171.88.2) and the new table of antigens received with the other test cells (2 to 11) of the kit "ID-DiaPanel-P", lot 45171.88.1 and "ID-DiaPanel", lot 45161.88.1.
  • Reason
    It was verified by the bio-rad quality control that the "id-diapanel-p 1" test kit, lot 05361.88.1, component of the kit "id-diapanel-p", lot 45171.88.1, 2017, is presenting results out of specification for polyglutination tests, which may lead to results with "nonspecific" positive reactions with samples from patients and / or donors.
  • Action
    Field Action Code AC 2017/01 triggered under the responsibility of the company DIAMED LATINO AMÉRICA SA Company will make payment.

Device

Trade name: ID-DIAPANEL P Technical name: IMMUNOHEMATOLOGY - ENZYME HEMACY / HEMATELIC REAGENTS R...

Manufacturer

DiaMed Latino América S.A