Events

Safety Alert for Trade Name: ADVIA Hematology System; 10345161959; Risk class I; Affected Model - ADVIA 560 Hematology System; Number of series affected: S020202, S020201, S020200, S020197.

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
    1867
  • Date
    2016-04-04
  • 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
  • Reason
    Siemens healthcare has identified that equipment with software version 1.4.2133 does not indicate the following flags: warning flag for low sample volumes (flag w) and morphology flags indicating the presence of immature granulocytes (g) and atypical lymphocytes (l). if the user uses the device with the affected software version, the results may be lower than expected.
  • Action
    Action code HI 16-01. Initiated by Siemens, it is sent a Letter to the Customer prepared in March 2016 with risk classification III (situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences). Recommendation to users and patients: To ensure that the patient sample quantity is sufficient to perform the assay, it is recommended to follow the requirements described in the ADVIA 560 Hematology System Operator's Manual. Siemens recommends a review of the abnormal results for white cells , confirming them with the manual differential when necessary.

Device

Trade Name: ADVIA Hematology System; 10345161959; Risk class I; Affected Model - ADVIA 560 Hemato...

Manufacturer

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