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Solana® bordetella complete assay

Official notice

22 May 2025

Last checked

22 May 2025

Medium riskHealth Canada

An official Health Canada notice concerns Solana® bordetella complete assay. 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 Published 2025-05-22.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77488

Official notice

2025-05-22

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77488

Lots

listed

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Affected products

Product 1

Affected products - Solana® Bordetella Complete Assay, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M308

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Diagnostic Hybrids - Also Trading Quidel, Solana® Bordetella Complete Assay.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

77488

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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