Events

Safety Alert for Multiplate® Analyzer Technical Name: Haemostasis Analyzer Registration Number ANVISA: 10287411001 Hazard Class: I Affected Model: Serial Numbers Affected: List of Serial Number Distributed in Brazil and Potentially Affected: 100120; 100296; 100933; 101328; 101340; 101342; 101430; 101438; 101439; 101527; 101567; 101612.

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
    2150
  • Date
    2017-01-13
  • 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
    USER RECOMMENDATION: - If you are using the Multiplate® analyzer with software version 2.04, print only with A4 size paper in portrait (portrait) orientation. You can check which software version you are using by looking at the title bar of the Multiplate® software application (see the figure of the notification letter). - If you are using paper size other than A4, please do not use the feature to display the reference and target ranges in graphic format. This functionality should be disabled for each test parameter, using the "Edit Tests" window. To deactivate this feature, by test setup, follow the instructions described in the Operator's Manual (V2.0, SW 2.04, Chapter Operation / Configuration / Editing Test Parameters, page 128). - The form contained at the end of the notification must be completed and returned to Roche Diagnóstica Brasil.
  • Reason
    Multiplate® analyzers using software version 2.04 can generate an erroneous impression of the target range and target range graph. the multiplate® analyzer software contains a feature that allows the reference range and target range to be displayed in the form of a horizontal bar chart. when this feature is enabled, the sample result will be displayed as a black vertical line within the bar graph of the target range / range to indicate its position relative to the defined ranges. when the sample results are printed, the bar graphs and the result line of the sample are also printed. if an end user changes print settings for paper size other than a4 or landscape orientation (landscape) then the position of the result line displayed within the reference range and target bar graph may not be correct.
  • Action
    Field Action Code SBN-CPS-2016-026 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in the field.

Device

Multiplate® Analyzer Technical Name: Haemostasis Analyzer Registration Number ANVISA: 10287411001...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH