Events

Safety Alert for Two products are affected by the field action. 1. Trade name: RUBELLA IGM IMMULITE / IMMULITE 1000 - Technical name: Rubella virus - Register 10345160740 - Affected lot (s): 333 and 334. ///. 2. Trade name: RUBEOLA IgM IMMULITE 2000 - Registration 10345160813 - Affected lots: 237, 236M, 238, 239 ///. Risk Class: III - Products that present a high risk to the user, the patient and / or the public health

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 Products Ltd.

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
    2009
  • Date
    2016-10-25
  • 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
    Recommendation to Users and Patients: Siemens recommends moving to IMMULITE / IMMULITE1000 Rubella IgM Kit 0337 lot or to IMMULITE 2000 / IMMULITE 2000 XPi Rubella IgM Kit lots 240 and above. A review, including retesting samples that are still in the time and storage conditions specified in the Instructions for Use, is recommended for non-reactive results = 0.47 to <0.9 previously generated. Retesting using Rubella IgM or another appropriate Rubella assay should be considered, will depend on the clinical context and the time of the initial test performed.
  • Reason
    Siemens healthcare diagnostics has confirmed an increase in inaccuracy in some patient samples for batches of rubella igm reagents for immulite® / immulite® 1000 and immulite® 2000 / immulite® 2000 xpi systems. these samples may display a percentage of coefficient of variation (% cv) greater than the precision performance data published in the instruction for use in non-reactive, indeterminate and reactive indexes.
  • Action
    Field Action No. BMI 16-20 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company issued Letter to Customers.

Device

Two products are affected by the field action. 1. Trade name: RUBELLA IGM IMMULITE / IMMULITE 100...

Manufacturer

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