Events

Safety Alert for ADVIA Chemistry Hemoglobin A1c_3 - Model Kit of 2x80 tests: agglutinator / Reagent - Registration nº 10345161848. Lots: Kit 2X80 tests lot 230; Kit 4X200 tests lot 230 and 231

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A..

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
    1700
  • Date
    2015-10-21
  • 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
    Positive BIAS in% HbA1c may be considered clinically significant and relevant to HbA1c values ​​and may result in a modification in therapy for hyperglycemia. Modification in the therapy of hyperglycemia may increase the risk of hypoglycemia occurring, which should be observed through monitoring of personal glucose and / or patient symptoms. .
  • Reason
    Siemens healthcare confirmed that batches of the hemoglobin a1c_3 / a1c_3m reagent used in the advia chemistry 1200, 1800, 2400 and xpt systems demonstrated an increase in the occurrence of bias positive in% hba1c determination. internal investigations carried out by siemens have demonstrated that batches of reagents 230 and 231 may exhibit an average positive bias of 0.6% for hba1c, ranging from -0.1% to 1.1% in hba1c units.
  • Action
    Siemens Healthcare recommends the following actions: - Discontinue use and discard batches of reagents identified in this Field Action; - Keep the Portuguese Letter CHC 15-19 (Alert Message) in your laboratory records for any future consultations.

Device

ADVIA Chemistry Hemoglobin A1c_3 - Model Kit of 2x80 tests: agglutinator / Reagent - Registration...

Manufacturer

Siemens Healthcare Diagnósticos S.A.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA