Events

Safety Alert for Reflotron Uric Acid, Record: 10287410183, Lots: 20750002, 21149403, 21836402, 21625703, 21506202, 22222403, 22311502, 22500902, 22618503, 22915302, 23179404, 23336508

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH.

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
    1655
  • Date
    2015-07-30
  • 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 company reports that although erroneous uric acid results are not likely to lead to an immediate serious adverse event, a medical risk due to the low false uric acid results in samples with a hematocrit above 48% can not be ruled out.
  • Reason
    After internal evaluation, roche diagnostics gmbh decided to reduce the hematocrit limit value from 55% to a maximum of 48% for reflotron uric acid products for the measurement of whole patient blood samples. during an internal investigation the manufacturer detected deviations in uric acid results in the reflotron system, which may be above the internal specification of 5% if hematocrit values ​​exceed 48%. this may lead to erroneously low uric acid results in whole blood samples with hematocrit greater than 48%. currently hematocrit values ​​are up to 55% for reflotron uric acid.
  • Action
    The company informs that a note will be added inside the Reflotron Uric Acid box informing about the reduction of the hematocrit limit value to a maximum of 48%. It further states that this information should be taken into account in measurements of whole blood samples from patients

Device

Reflotron Uric Acid, Record: 10287410183, Lots: 20750002, 21149403, 21836402, 21625703, 21506202,...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH