Events

Safety Alert for IMX T 4 FREE REAGENTS, Reg. No. 10055310036, list no. 2222-20 lot no. 01550Q100 and FREE T4 CONTROLS, Reg. No. 10055311050, list no. 9C03-10, lot no. 95881Q100

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATÓRIOS DO BRASIL LTDA.

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
    738
  • Date
    2003-06-25
  • 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
    Check if you received communication from 16.07.2003 of ABBOTT LABORATORIES DO BRASIL LTDA, if you have not received contact ABBOTT LABORATORIES DO BRASIL LTDA by telephone 11 5367000 or your local representative. ----- BRAZIL 10/09/2003 - Date of Beginning of the Collection: 06/16/2003 ---- /////// ---- Completion Date of the Collection 21/08/2003.
  • Reason
    The mid-level control of free t4 controls, lot # 95881q100, showed a high value for the range mentioned in the instructions for use of the product during investigation of an occurrence. the free t4 controls, lot # 95881q101 (lots not received in brazil) is a sublot of 95881q100, from which complaints about the same occurrence of out of range controls were received. the imx mode 1 calibrator, lot # 96726q100 is the batch of calibrator found on the imx t4 free reagents, batches # 01550q100. this batch of mode 1 calibrator was manufactured with the same components as the control batches mentioned. this lot has been shown to produce an underestimation of the free t4 level in patient samples of up to 29%.
  • Action
    Check if you received communication from 16.07.2003 of ABBOTT LABORATORIES DO BRASIL LTDA, if you have not received contact ABBOTT LABORATORIES DO BRASIL LTDA, by telephone 11 5367000 or your local representative.

Device

IMX T 4 FREE REAGENTS, Reg. No. 10055310036, list no. 2222-20 lot no. 01550Q100 and FREE T4 CONTR...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA