Events

Recall of QUIKLYTE DILUTION CHECK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

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
    22220
  • Event Risk Class
    III
  • Event Initiated Date
    2015-02-25
  • 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
    Siemens healthcare diagnostics has confirmed complaints of failing dilution checks when using quiklyte dilution check lot 4md707. this lot may exhibit a positive bias possibly beyond 5% that can result in a dilution check failure or may result in an unnecessary correction if the bias is between 1 - 5%. a dilution check failure prevents complete installation of the quiklyte integrated multisensor as described in the dimension operator's guide.

Device

QUIKLYTE DILUTION CHECK
  • Model / Serial
    Model Catalog: 10444872 (Lot serial: LOT 4MD707); Model Catalog: S640 (Lot serial: LOT 4MD707)
  • Product Description
    QUIKLYTE DILUTION CHECK
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC