Events

Safety Alert for IMx Kit B12 Reagent No. batch 75782M200

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 - Divisão Diagnósticos.

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
    711
  • Date
    2002-07-25
  • 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
    The investigation of this issue is under way. Abbott, is working to speed up the replacement of the IMx B12 reagent product No. batch 75782M200, so we recommend alternative methods for performing the test. For more information contact your local representative or directly with Abbott Laboratories of Brazil LTDA - Diagnostics Division (0xx11 ) - 5536.7000
  • Reason
    Studies with the reagent imx b12 assay no. batch 75782m200, performed by abbott laboratories, have demonstrated that calibration failure, non-limiting controls, and non-reproducibility of patient outcomes may occur.
  • Action
    . Review the results of the controls for the reagent IMx B12 assay No. lot 75782M200. . Discontinue use of reagent IMx B12 batch No. 75782M200 verify that the results of the low control are out of range as recommended in the package insert. If the low control is off (above and below the limits for low control), it is recommended to retest patients with results inconsistent with the clinical evaluation made by the physician. If the low control is within the limits described in the package insert, no action of retesting the patient results is necessary. . No action is required for the Medium and High controls.

Device

IMx Kit B12 Reagent No. batch 75782M200

Manufacturer

Abbott Laboratórios do Brasil LTDA - Divisão Diagnósticos
  • Source
    ANVSANVISA