Events

Safety Alert for MOLECULAR FAMILY HLA SSO. Registration at Anvisa: 10358940014. Lots affected: consult www.http: //portal.anvisa.gov.br/wps/wcm/connect/9b75e08046226d34a17dbde732f69725/information+to+user+users. pdf? MOD = AJPERES

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Life Technologies Brasil..

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
    1052
  • Date
    2011-03-15
  • 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
    The product is used for histocompatibility determination. According to the registry holder, non-validated software has been used for quality control testing of RELI SSO products. Using a comparative manual analysis method, the company has identified false positive results from the use of this software, which may lead to erroneous typing or do not provide any typing. For more information regarding the affected products, please consult http://portal.anvisa.gov.br/wps/wcm/connect/9b75e08046226d34a17dbde732f69725/informations+to+usersus.pdf ? MOD = AJPERES
  • Reason
    Possibility of occurrence of false positive results.
  • Action
    Users who have affected kits in their inventories should segregate these products, discontinue their use immediately, and communicate the registration holder via a specific form (available at www.hp.com/go/wps/wcm/). connect / 4159c8804622738fa1d4bde732f69725 / Formul% C3% A1rio.pdf? MOD = AJPERES). Questionable results from the use of this product should be reassessed.

Device

MOLECULAR FAMILY HLA SSO. Registration at Anvisa: 10358940014. Lots affected: consult www.http: /...

Manufacturer

Life Technologies Brasil.