Events

Recall of TEG HEMOSTASIS ANALYZER - CONTROLS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HAEMONETICS CORPORATION DBA HAEMOSCOPE CORPORATION.

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
    133213
  • Event Risk Class
    III
  • Event Initiated Date
    2015-01-26
  • 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
    Specific lots of level ii control kits may produce results with an out-of-range high ma (maximum amplitude). the discordant high result may be elevated by 1 - 6 mm yielding results as high as 47 mm.

Device

TEG HEMOSTASIS ANALYZER - CONTROLS
  • Model / Serial
    Model Catalog: 8002 (Lot serial: HM09292); Model Catalog: 8002 (Lot serial: HM09226); Model Catalog: 8002 (Lot serial: HM09217); Model Catalog: 8002 (Lot serial: HM09232); Model Catalog: 8002 (Lot serial: HM09276); Model Catalog: 8002 (Lot serial: HM09285); Model Catalog: 8002 (Lot serial: HM09200)
  • Product Description
    TEG HEMOSTASIS SYSTEM LEVEL II CONTROL
  • Manufacturer
    HAEMONETICS CORPORATION DBA HAEMOSCOPE CORPORATION

Manufacturer

HAEMONETICS CORPORATION DBA HAEMOSCOPE CORPORATION