Urgent Product Defect Alert
GPs are advised of a product defect alert for ColoVantage Home-Faecal Immunochemical Test Kits also known under the brand names ColoVantage Home Bowel Screening Test, Bowelscan, BowelCare and Bowelscreen Aotearoa.
A higher than expected rate of positive test results for blood in stool of patients undergoing screening for colorectal cancer has been observed.
This anomaly is limited to distributed test card lot T180203.
Advice to GPs is:
- If your patient has already had a colonoscopy it is not necessary to repeat the FIT;
- If your patient is scheduled for a colonoscopy, guidelines support a followup. Repeating the FIT is not recommended;
- The National Health and Medical Research Council (NHMRC) Clinical practice guidelines for the prevention, early detection and management of colorectal cancer recommends that “Participants with positive iFOBT results should have follow-up investigation... Repeating the iFOBT test after a positive result carries the risk of a falsely negative test result on the second occasion because of low levels of bleeding from a cancer or adenoma, intermittent bleeding, or uneven distribution of blood in the stools”.; and
- If you feel it is appropriate, you may wish to inform your patient of this Product Defect Alert notification; and
- Doctors are further advised to note that this product is in no way connected with the test kits used in the National Bowel Cancer Screening Program (NBCSP).
For more information on recall actions visit the TGA website.