Recall of COBAS C 111 ALBT2 (TINA-QUANT)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROCHE DIAGNOSTICS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70640
  • Event Risk Class
    III
  • Event Initiated Date
    2012-12-13
  • Event Country
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Potential for linearity defect with the tina-quant albumine urine has been identified by the manufacturer leading to a temporary reduction of the upper measuring range. this assay can be used on the cobas c111 system.

Device

  • Model / Serial
    Model Catalog: 05401500190 (Lot serial: 67231001)
  • Product Description
    Tina-Quant Albumine Urine Assay on Cobas C 111
  • Manufacturer

Manufacturer

  • Manufacturer Address
    LAVAL
  • Manufacturer Parent Company (2017)
  • Source
    HC