Events

Recall of COBAS 4800 HPV AMPLIFICATION/DETECTION KIT

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
    18317
  • Event Risk Class
    III
  • Event Initiated Date
    2017-05-04
  • 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
    Quality data sources have indicated that specific lots of the cobas 4800 hpv amplification/detection kits ce-ivd are generating an increase frequency of invalid positive control results for multiple channels. in order to limit the potential of invalid pc generation the shelf life of these products were shortened to 6 months pending investigation of the root cause.

Device

COBAS 4800 HPV AMPLIFICATION/DETECTION KIT
  • Model / Serial
    Model Catalog: 05235901190 (Lot serial: > than 10 contact MFR); Model Catalog: 05235910190 (Lot serial: > than 10 contact MFR)
  • Product Description
    COBAS 4800 HPV AMPLIFICATION/DETECTION KIT
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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