eSwab
Brand(s)
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:
Alert / recall type
Health product recall
Category
Health products - Medical devices
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
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