Recall MonitorHealth Products
Solana® Bordetella Complete Assay
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Microbiology
Product: Solana® Bordetella Complete Assay
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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