Events

Safety Alert for Series 50 Supreme Blood Glucose Test Tapes. Lot #: 01031B, 12150B, 12220B, 12280B, 12290B; Part # 880050; NDC # 08317-8850-50; UPC # 0-15482-88005-7

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Hypoguard USA Inc A Medisys Group Co.

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
    399
  • Date
    2002-02-22
  • 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 glucose test above may register a low inaccurate reading, which may cause the user to underestimate the glucose level. the manufacturer voluntarily initiated a correction by letter dated 4 january 2002.
  • Action
    Make sure you received the letter dated January 4, 2002, mailing card, and Hypoguard customer notification letter. Identify and isolate any affected product in your inventory. Complete the customer's response card, and return by mail to Hypoguard. Using the notification letter, notify any of your customers who have received this product. If you have a product in your inventory, or for more information, contact your local Hypoguard representative. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Series 50 Supreme Blood Glucose Test Tapes. Lot #: 01031B, 12150B, 12220B, 12280B, 12290B; Part #...

Manufacturer

Hypoguard USA Inc A Medisys Group Co
  • Source
    ANVSANVISA