Events

Safety Alert for CREATININE - R1 10x20ml + R2 2x25ml + Standard 1x3 ml; R1 1x 200ml + R2 1x50ml + Standard 1x3ml; R1 2x200ml + R2 1x100ml + Standard 1x3ml; R1 4x40mL + R2 4x10mL + 1x3mL Standard - ALL LOTS MANUFACTURED.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by KOVALENT 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
    1184
  • Date
    2012-09-25
  • 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
    There is a median probability of an incorrect creatinine value occurring in urine samples from patients with alkaptonuria (due to homogentisic acid). The severity and estimated risk is low if the test results are assured by the laboratory's internal quality control. The results of the tests should be checked critically by the health professional. Anvisa accompanies this Action. #### TERMINATION - 03/10/2012 - The company forwards Notice of Completion of the Field Action.
  • Reason
    High concentrations of hga in urine samples may interfere with photometric measurement with the enzymatic creatinine method and to a lesser extent with the jaffé method.
  • Action
    The results of the tests must be ensured by the internal quality control of the laboratory. The results of the tests should be checked critically by the health professional. In addition, the health professional should evaluate the need for confirmatory tests, as well as take into consideration the patient's medical history and examination. In case of a discrepant result with the patient's clinic, confirm the result using a different method. Check the instruction for use of the product to evaluate information on possible interference.

Device

CREATININE - R1 10x20ml + R2 2x25ml + Standard 1x3 ml; R1 1x 200ml + R2 1x50ml + Standard 1x3ml; ...

Manufacturer

KOVALENT DO BRASIL LTDA