Events

Recall of COAT-A-COUNT TSH IRMA

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
    25534
  • Event Risk Class
    III
  • Event Initiated Date
    2012-11-23
  • 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 an under-recovery of dose values with some vials of coat-a-count irma tsh calibrators tsi4 (level b) tsi5 (level c) tsi8 (level f) and tsi9 (level g) lot 035 in the listed reagent kit lots for product code iktsx.

Device

COAT-A-COUNT TSH IRMA
  • Model / Serial
    Model Catalog: IKTSX (Lot serial: 743); Model Catalog: IKTSX (Lot serial: 742)
  • Product Description
    COAT-A-COUNT IRMA TSH KIT IKTSX
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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