Events

Safety Alert for CELL-DYN 1700, Registration 10055310574 - CELL-DYN 1700 CS, Registration 10055310576 - CELL-DYN 1600 CS (120v) Registration 10055310125 - CELL-DYN 1600 CS (220v) Registration - 10055310125 - CELL-DYN 1400, c / RS 232 Registration 10055310122 - CELL-DYN 1400 CS Registration 100553105122 and CELL-DYN 1400 Registration 10055310122

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratórios do Brasil Ltda - Divisão Diagnósticos.

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
    797
  • Date
    2004-08-18
  • 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
    Note the existence of abnormal platelet histogram with an MCV <7) fl parameter, as it may be a case of microcytosis and thrombocytopenia, with no URI alert message appearing. According to the results, of red blood cells and platelets, by an alternative manual or automatic method, according to the laboratory procedure. The platelet histogram demonstrates a normal or typical platelet histogram, which should be considered as the visual validation criterion of the result. As well as, patient boundaries indicate an abnormality of outcome, and are used to repeat and confirm by alternative methods manual or automated, according to the laboratory procedure. You are requested to: Keep a copy of the communication received in your files and attached to the CEL-DYN 1400, 1600 and 1700 instrument manuals. Forward a copy of the communication to the physician. Fill in the RESPONSE PROTOCOL and send the Customer Service Center. Any additional questions or clarifications, please contact the Customer Service Center, Telephone 0800 119099
  • Reason
    Software-related occurrence: the algorithm that governs the uri signaling mechanism inhibits the display of the signal for blood samples that are characterized by low values ​​in certain areas of sample histogram. a blood sample with combination of thrombocytopenia and microcyst of red blood cells is not likely to trigger uri signaling. the design of the software in combination with the characteristics of certain patient samples is the cause of the occurrence.
  • Action
    Investigation into the cause of occurrence was completed. An initial preventive action was implemented. The initial preventive action consists of a review of the impact of this occurrence on other CELL-DYN Séire 1000 platforms. The CELL-DYN 1400 and CELL-DYN 1600 analyzers have essentially the same platelet algorithm as the CELL-DYN 1700. They may, however , exhibit the same URI signaling behavior for platelets with respect to thrombocytopenic / microcytosis samples, such as those of patients with thalassemia and idiopathic thrombocytopenic purpura.

Device

CELL-DYN 1700, Registration 10055310574 - CELL-DYN 1700 CS, Registration 10055310576 - CELL-DYN 1...

Manufacturer

Abbott Laboratórios do Brasil Ltda - Divisão Diagnósticos
  • Source
    ANVSANVISA