Events

Recall of QUALICHECK 3

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RADIOMETER MEDICAL APS.

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
    28157
  • Event Risk Class
    III
  • Event Initiated Date
    2016-03-21
  • 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
    Radiometer has recently become aware that supplementary inserts for some lots of s7335 (autocheck 3+ level 1) distributed in connection with the release of sofware version 6.16 for the abl800 series analyzers state an incorrect control range for pco2 in "abl810/820/830 sw more than v6.16" column. on the incorrect inserts both the low and high limits are offset by +1.3 mmhg for all affected lots. this also applies to the value in the barcode in the insert. the bar code is used to upload the values to the analyzer.

Device

QUALICHECK 3
  • Model / Serial
    Model Catalog: S7335 (Lot serial: 0335); Model Catalog: S7335 (Lot serial: 0304); Model Catalog: S7335 (Lot serial: 0333); Model Catalog: S7335 (Lot serial: 0332); Model Catalog: S7335 (Lot serial: 0331); Model Catalog: S7335 (Lot serial: 0330); Model Catalog: S7335 (Lot serial: 0329); Model Catalog: S7335 (Lot serial: 0328); Model Catalog: S7335 (Lot serial: 0327); Model Catalog: S7335 (Lot serial: 0326); Model Catalog: S7335 (Lot serial: 0325); Model Catalog: S7335 (Lot serial: 0324); Model Catalog: S7335 (Lot serial: 0323); Model Catalog: S7335 (Lot serial: 0322); Model Catalog: S7335 (Lot serial: 0321); Model Catalog: S7335 (Lot serial: 0305); Model Catalog: S7335 (Lot serial: 0334)
  • Product Description
    QUALICHECK 3
  • Manufacturer
    RADIOMETER MEDICAL APS

Manufacturer

RADIOMETER MEDICAL APS