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Health Canada Medical devices

eSwab

Issued December 7, 2021
Issue
Copan has received some reports of Bordetella parapertussis false positives observed at high cycle threshold values (Ct, Cycle threshold) when combining eSwab with some in-house PCR protocols and the Pathofinder BV-RealAccurate Quadruplex Bordetella PCR kit due to non-viable B. parapertussis nucleic-acids traces. Recall start date: Nov 5, 2021
Hazard description
Inaccurate test or measurement results
Product
Product name
eSwab
Reference
ID
RA-63686