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Product Recall: ColoVantage Home-Faecal Immunochemical Test Kits

Product Recall: ColoVantage Home-Faecal Immunochemical Test Kits

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