Events

Safety Alert for ADVIA Chemistry XPT Technical Name: Biochemical Analyzer ANVISA Registration Number: 10345161947 Hazard Class: II Affected Model: ADVIA Chemistry XPT Affected Batch / Serial Numbers: CA1275001020102; CA1275001600160; CA1275001630163

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; Siemens Healthcare Diagnostics Inc..

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
    2096
  • Date
    2016-09-12
  • 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
    In order to avoid any possibility of inconsistent ISE results due to disconnected electrodes, make sure that the electrodes are fully connected after replacement, washing or maintenance activities by performing ISE calibration and processing of Quality Controls. If the electrode is not connected properly, the calibration will fail and the operator should perform the usual troubleshoot procedures. Perform the 2 levels of Quality Control at least once a day to confirm the perfect performance of the system.
  • Reason
    It is possible that the ise module will exhibit discrete unbonded results for sodium, potassium and chlorine when the respective electrode (including the reference electrode) remains switched off after replacement, washing or maintenance activities. the calibration and the 2 levels of quality control will fail if the electrode stays off. the instructions for use (ifu) for the ise electrodes clearly state the need to calibrate the ise after the replacement and processing of the two levels of control before testing the patient samples. after the special maintenance - wash, the online help documentation clearly informs the need to calibrate and process controls.
  • Action
    Field Action Code CHI 15-03 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

ADVIA Chemistry XPT Technical Name: Biochemical Analyzer ANVISA Registration Number: 10345161947 ...

Manufacturer

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