Events

Recall of IGG-2 (TINA-QUANT IGG GEN.2) FOR USE ON C701 ANALYZER

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
    90582
  • Event Risk Class
    III
  • Event Initiated Date
    2017-10-10
  • 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
    Following internal investigation the manufacturer identified a situation where the specifications for qc recoveries could not be fulfilled for the sensitive applications (urien-csf) for the tina-quant igg gen-2 assay (cat #05220718190 lot 26358701) on cobas c701-702 analyzers. this situation has no impact in canada since the identified lot will not be distributed to users.

Device

IGG-2 (TINA-QUANT IGG GEN.2) FOR USE ON C701 ANALYZER
  • Model / Serial
    Model Catalog: 05220718190 (Lot serial: 26358701)
  • Product Description
    IGG-2(TINA-QUANT IGG GEN.2) FOR USE ON C701 ANALYZER
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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