Events

Recall of TINA-QUANT D-DIMER GEN.2 FOR ROCHE COBAS C 111 ANALYZERS

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

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
    143707
  • Event Risk Class
    I
  • Event Initiated Date
    2010-08-13
  • Event Country
    Canada
  • 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
    The impacted lots show an unusual systematic negative biais of 15% when used together with serum based calibrators and controls.The false negative results could pose a patient at risk of not being timely diagnosed for thrombosis and embolism.

Device

TINA-QUANT D-DIMER GEN.2 FOR ROCHE COBAS C 111 ANALYZERS
  • Model / Serial
    Model Catalog: 05077753190 (Lot serial: 62841101); Model Catalog: 04912497190 (Lot serial: 62838001); Model Catalog: 04912551190 (Lot serial: 62837701)
  • Product Description
    TINA-QUANT D-DIMER GEN.2 FOR ROCHE COBAS C111 ANALYZERS
  • Manufacturer
    ROCHE DIAGNOSTICS GMBH

Manufacturer

ROCHE DIAGNOSTICS GMBH
  • Manufacturer Address
    MANNHEIM
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    HC