Reissue of 85 test kits

Page last updated: 04 July 2018

PDF printable version of Statement from the Australian Department of Health (PDF 39 KB)

Statement from the Australian Department of Health

11 July 2018

National Bowel Cancer Screening Program re-issuing test kits to some participants as a precautionary measure

A small number of participants in the National Bowel Cancer Screening Program who did their test kit between 2 January and 31 May 2018 are being asked to do a new test kit because their original test was received at the laboratory after 14 days. This was a contained incident and there is no issue with the test itself.

A total of 85 test kits processed by the laboratory earlier this year may have been received and tested outside of the manufacturer’s specification of 14 days. Quality procedures for this test recommend a replacement kit be provided to ensure an accurate result is obtained. This represents around 0.02% of the more than 370,000 test kits analysed between January and May 2018.

It is unlikely that the new test will provide a different result, but 83 people are now receiving letters to advise them of this situation and the Department of Health is strongly encouraging these people to do the test a second time when they receive it in the mail to best ensure the accuracy of their result. Any nominated GPs are also being notified. A further two participants are being contacted directly by the laboratory to encourage them to see their GP for advice on further testing.

This does not affect the vast majority of people who took part in the Program this year. Only those people affected by this issue will be contacted. If you are not contacted by the laboratory, your results are not affected.

The Department of Health can reassure the affected participants that these measures are being taken as a precautionary measure and with the advice of our expert clinical advisors to the Program.

The issue was detected as part of the contracted pathology provider’s internal quality assurance checks. The contracted pathology provider has implemented measures to ensure this does not happen again.

This free screening program is estimated to prevent 59,000 deaths between 2015 and 2040. The Department of Health urges Australians to participate in the National Bowel Cancer Screening Program and feel confident that this is a highly effective program in the fight against bowel cancer.

Information about the Program is available from the National Bowel Cancer Screening Program website at (www.cancerscreening.gov.au/bowel)