PRODUCT:
ColoVantage Home-Faecal Immunochemical Test Kits
Brand Names:
ColoVantage Home Bowel Screening Test
Bowelscan
BowelCare
Bowelscreen Aotearoa
Product codes:
15015, 15034, 15032, 15030, 15024, 18001, 18002, 18004
Containing Test Card Lot Number:
T180203
Expiry Date:
06 Feb 2020
ARTG Number:
226537
(Enterix Australia Pty Ltd – Clinical chemistry biological screening IVDs)
An in vitro diagnostic medical device (IVD)
REASON:
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