Events

Recall of COBAS INTEGRA TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR (STFR)

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
    153567
  • Event Risk Class
    III
  • Event Initiated Date
    2015-07-08
  • 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
    Roche received a customer complaint regarding elevated imprecision and too high recovery of stfr control set level 1 and dup alarms during calibration with the reagent tq soluble transferrin receptor (stfr). the issue of elevated imprecision was confirmed by internal investigations on lot 606449 on cobas c 501 showed elevated imprecision of up to 8.9%. the other current reagent lots are not affected by this issue.

Device

COBAS INTEGRA TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR (STFR)
  • Model / Serial
    Model Catalog: 20763454122 (Lot serial: 60644901)
  • Product Description
    COBAS INTEGRA TINA-QUANT SOLUBLE TRANSFERRIN RECE
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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