Events

Safety Alert for ID-DiaCell I, II, III (Code 004310) Lot 45181.24.1; ID-DiaCell ABO / I, II (Code 003610) Lot 45001.24.1; ID-DiaCell ABO / I, II, III (Code 003618) Lot 45011.24.1; ID-DiaPanel (Code 004114) Lot 45161.46.1; ID-DiaCell I, II (Code 003613) Lots 45151.45.1 and 45151.46.1; ID-DiaCell ABO (A1, A2, B) (Code 003617) Lot 45081.24.1; ID-DiaCell ABO (A1, B) (Code 003624) Lot 45091.24.1; ID-DiaCell POOL (Code 003630) Lot 06070.63.1; DiaCell-MP ABO (A1-B) (Code 109897) Lot 45422.24.1. ANVISA registration no. 80004040131 (products registered in the same family).

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

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
    1342
  • Date
    2013-12-19
  • 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
    False negative results of anti-FYa and anti-Fyb may represent a significant risk for patients with sickle cell anemia, since the index of these antibodies is usually high in these patients. Check additional information in the Alert Message posted by the company at (WAITING FOR PUBLICATION).
  • Reason
    Reduced reactivity for some antigens (fya, fyb and mns), which can lead to false negative results.
  • Action
    ASK QUICKLY in your inventory of the products at risk, segregate them and avoid their use. Check the following steps of manufacturer communication, product destruction and refund in the Company Alert Message (see link in the Clarification field).

Device

ID-DiaCell I, II, III (Code 004310) Lot 45181.24.1; ID-DiaCell ABO / I, II (Code 003610) Lot 4500...

Manufacturer

DIAMED LATINO AMERICA SA.