Events

Recall of HemoCue Glucose 201 RT Microcuvettes (used with HemoCue Glucose 201 RT and HemoCue Glucose 201 RT DM analysers). 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 Radiometer Pacific 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-2016-RN-00237-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00237-1
  • 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 recently become aware of a production related problem that affects hemocue glucose 201rt microcuvettes. during an internal investigation a minor deviation was found, which may cause the microcuvettes to not perform as intended. there was an incorrect position for the sleigh in the final punch which affects the grouping of cuvettes with respect to measuring level. the accuracy of glucose levels below 4.1mmol/l may deviate by up to +0.9 mmol/l, resulting in falsely high results. there is also a low possibility that results in the range of 6.6-8.8 mmol/l may be falsely elevated.No harm to patients has been reported. however, there is a risk that a false high result for low glucose levels could lead to delayed or missed diagnosis of hypoglycaemia, as clinical symptoms are not always present.
  • Action
    Radiometer is advising users that the affected product can continue to be used in adults. The affected lots should not be used in neonates or infants. Users should verify low or marginal results via another method.

Device

HemoCue Glucose 201 RT Microcuvettes (used with HemoCue Glucose 201 RT and HemoCue Glucose 201 RT...
  • Model / Serial
    HemoCue Glucose 201 RT Microcuvettes (used with HemoCue Glucose 201 RT and HemoCue Glucose 201 RT DM analysers). An in vitro diagnostic medical device (IVD)Product Code: 114701Batch Numbers: 1506998, 1507909, 1508920, 1405990, 1407901, 1410921, 1411931, 1501939, 1501950, 1504972, 1506995 ARTG Number: 222660
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd