Events

Recall of LAMB2 (TINA-QUANT LAMBDA GEN.2 FOR COBAS C 311 AND COBAS C 501/502)

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
    55525
  • Event Risk Class
    III
  • Event Initiated Date
    2017-11-02
  • 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
    Internal investigations revealed an interference with lipemia and rheumatoid factors in the increased rerun mode for tina-quant kappa gen.2 and tina-quant lambda gen.2. as a consequence the increased rerun function for both assays will be removed from the respective method sheets and the new values and new ratios will be changed in the next version of the method sheets.

Device

LAMB2 (TINA-QUANT LAMBDA GEN.2 FOR COBAS C 311 AND COBAS C 501/502)
  • Model / Serial
    Model Catalog: 06749992190 (Lot serial: all lots); Model Catalog: 06749976190 (Lot serial: all lots)
  • Product Description
    LAMB2 (TINA-QUANT LAMBDA GEN.2 FOR COBAS C 311 AND COBAS C 501/502);KAPP2 (TINA-QUANT KAPPA GEN.2 FOR ROCHE/HITACHI MODULAR P AND COBAS C
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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