Official recall record
Solana® Bordetella Complete Assay
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-05-22
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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