Solana® Bordetella Complete Assay

Solana® Bordetella Complete Assay Recall The Solana® Bordetella Complete Assay, a diagnostic test used to detect bacterial respiratory infections, is being recalled across Canada due to performance issues. This Class I recall indicates the test may not perform as intended. The recall affects all users of this assay in Canada, including healthcare facilities and laboratories.

Product
Solana® Bordetella Complete Assay
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2025-05-22
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/ffc69dbd-3dba-4f79-a580-c782a988c901