Solana® Bordetella Complete Assay
Last updated
Summary
Product
Solana® Bordetella Complete Assay
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Solana® Bordetella Complete Assay |
More than 10 numbers, contact manufacturer. |
M308 |
Issue
QuidelOrtho received complaints regarding false positive results from customers testing with the Solana® Bordetella complete assay. The false positive results are associated with the Bordetella parapertussis (bpp) results (only) of the assay and only for the specific lot numbers listed above. The Bordetella pertussis (bp) results are not affected.
Recall start date: May 7, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Microbiology
Companies
| Diagnostic Hybrids, Inc. - Also Trading As Quidel Corporation |
| 2005 East State Street, Athens, Ohio, United States, 45701 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77488
Get notified
Receive notifications for new and updated recalls and alerts by category.