Health product recall

eSwab

Last updated

Summary

Product
eSwab
Issue
Medical devices - Inaccurate test or measurement results
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or serial number

Model or catalog number

eSwab

All lots expiring on/before 12/2022

480CE

Sterile single use sample collection pack containing eSwab MRSA system

All lots expiring on/before 12/2022

493CE02

Sterile single use sample collection pack containing eSwab MARSA system

All lots expiring on/before 12/2022

493CE03

eSwab LQ Amies urethral nylon flocked applicator

All lots expiring on/before 12/2022

483CE

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

Additional information

Details
Original published date: 2021-12-10
Alert / recall type
Health product recall
Category
Health product - Medical device
Companies
Copan Italia S.P.A.

Via F. Perotti, 10, Brescia

Italy, 25125

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63686