Events

Safety Alert for Trade name: PreciControl Varia Technical name: MULTI-PARAMETER CONTROLS OF ONE OR MORE CONCENTRATIONS - CLASS II Registration number ANVISA: 10287410955 Hazard class: II Model affected: Serial numbers affected: 18928501

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
    2151
  • Date
    2017-01-05
  • 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
    Actions taken by Roche Diagnóstica: Lot 189285-01 of PC Varia, has been temporarily blocked for reworking and updating of the package insert (see updated package insert). The subsequent batch of PC Varia (221451) is already available at the factory for import. The limitation of the internal software, which caused the problem, has already been fixed. Actions to be taken by the customer / user The incorrect target value is only present in the PreciControl Varia, lot 189285-01, level 2, for the Elecsys PTH assay on the Elecsys 2010 / cobas and 411 analyzers. Users must enter the correct value manually, as supplied on the new Data Sheet attached to this communication: • A batch-specific reagent value has been provided for Elecsys PTH lot 143251. • For all other batches of Elecsys PTH (incl. be used. For further questions and support, please do not hesitate to call our CEAC Service Center - 08007720295 or your Roche Diagnostica Brasil Ltda representative. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Reason
    Roche diagnostics gmbh, the manufacturer of the product involved in this notification, during routine qc activities was aware of a bar code error and the precicontrol (pc) variable sheet, lot 18928501: incorrect target values ​​were being provided for the elecsys pth test (code 11972103122) for the elecsys 2010 / cobas and 411 instruments for the pc variable level 2. we emphasize that the following products are not affected by this question: • pc varia control level 1 target values ​​for pth ono elecsys 2010 / cobas and 411 • pc varia control level 1 and 2 target values ​​for pth in modular analytics e170 / cobas and 601 / cobas and 602 • any other panel applications of bone markers or anemia also present in pc varia.
  • Action
    Field Action Code SBN-CPS-2016-025 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will update, correct or supplement the instructions for use.

Device

Trade name: PreciControl Varia Technical name: MULTI-PARAMETER CONTROLS OF ONE OR MORE CONCENTRAT...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH