Events

Recall of ACL TOP - COAGULATION ANALYZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INSTRUMENTATION LABORATORY CO..

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
    38136
  • Event Risk Class
    III
  • Event Initiated Date
    2012-08-15
  • 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
    The manufacturer is conducting a mandatory parameter upgrade(p-14.8)based on two fibrinogen-c reporting issues. issue number one was a result of 3 customer complaints where low abnormal fibrinogen sample reports were reporting as normal. issue two was identified by the manufacturer during r&d where high fibrinogen samples were reported as low.

Device

ACL TOP - COAGULATION ANALYZER
  • Model / Serial
    Model Catalog: 0000280020 (Lot serial: 03110101 to 11111174); Model Catalog: 0000280030 (Lot serial: 03110101 to 11111174); Model Catalog: 0000280050 (Lot serial: 09120101 to 12060240); Model Catalog: 0000280040 (Lot serial: 08010200 to 12062270); Model Catalog: 0000280010 (Lot serial: 09080100 to 12060403); Model Catalog: 0000280000 (Lot serial: 03110101 to 11111174)
  • Product Description
    ACL TOP BASE TOP CTS TOP 700 LAS
  • Manufacturer
    INSTRUMENTATION LABORATORY CO.

Manufacturer

INSTRUMENTATION LABORATORY CO.
  • Manufacturer Address
    BEDFORD
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    HC