Events

Recall of HemoCue Hb 201 Microcuvettes (an in vitro diagnostic medical device (IVD))

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by HemoCue Australia Pty 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
    RC-2013-RN-00825-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00825-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Hemocue has become aware of a production related problem that affects some single pack pouches of certain lots of hemocue hb 201 microcuvettes, where the foil within the pouch has been damaged. if a single pack pouch is damaged, the microcuvettes can be exposed to moisture the cuvettes will not fill properly and no measurement will be given.
  • Action
    HemoCue is asking users to discard any affected microcuvettes as per the Instructions for Use. Replacement of affected units can be arranged by consulting HemoCue.

Device

HemoCue Hb 201 Microcuvettes (an in vitro diagnostic medical device (IVD))
  • Model / Serial
    HemoCue Hb 201 Microcuvettes (an in vitro diagnostic medical device (IVD))Lot Numbers: 12086555, 1208660, 1209669, 1209674, 1210688, 1211697, 1301708, 1301717, 1322723, 1303734ARTG Number: 137082
  • Manufacturer
    HemoCue Australia Pty Ltd

Manufacturer

HemoCue Australia Pty Ltd
  • Source
    DHTGA