Events

Recall of MAS CARDIOIMMUNE XL LEVEL 1 2 3

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

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
    43346
  • Event Risk Class
    III
  • Event Initiated Date
    2014-10-22
  • 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
    Customers reported vial-to-vial variation of b-type natriuretic peptide-32 (bnp-32) and creatine kinase-mb (ck-mb) recovery in cardioimmune xl level 1 part number cai-xl 1 lot number cxl16011. within the same kit some vials would recover consistently within the range of published value assignment but other vials would recover dramatically outside the value assignment range (higher for bnp-32 and lower for ck-mb).

Device

MAS CARDIOIMMUNE XL LEVEL 1 2 3
  • Model / Serial
    Model Catalog: CAI-XL1 (Lot serial: CXL16011)
  • Product Description
    MAS CARDIOIMMUNE XL LEVEL 1 2 3
  • Manufacturer
    DIAGNOSTIX LTD

Manufacturer

DIAGNOSTIX LTD