Events

Safety Alert for ABS2000 COMPUTERIZED BLOOD BANK INSTRUMENTS

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

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
    61
  • Date
    2000-12-13
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The safety alarm for the instruments mentioned was removed from the screen and crossmatch analysis; alarm still applies to group analysis. the manufacturer began a recall through correspondence sent on december 13, 2000.
  • Action
    MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE OF DECEMBER 13, 2000 FROM IMMUCOR. IMMUCOR DECLARES THAT UNLIMITED FIELD CORRECTIONS ARE COMPLETED, CUSTOMERS ARE ADVISED TO CONTINUE VALIDATING GROUP RESULTS (ABO / RH) THROUGH AN ALTERNATIVE METHOD. FOR FURTHER INFORMATION, OR TO SCHEDULE CORRECTION, CONTACT IMMUCOR BY TEL. (800) 829-2553 OR BY TEL. (770) 441-2051

Device

ABS2000 COMPUTERIZED BLOOD BANK INSTRUMENTS

Manufacturer

IMMUCOR INC
  • Source
    ANVSANVISA