Solana Bordetella Complete Assay Kit Recalled for False Positive Results
Ortho-Clinical Diagnostics is recalling the Solana Bordetella Complete Assay Kit (Model M308) because it may produce false positive results for Bordetella parapertussis at a rate of up to 16.7%.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The product is an FDA Class II diagnostic assay with a significant false positive rate (16.7%) for a clinically important respiratory pathogen. Although no reported illnesses or injuries are stated in the source, the risk of false positive results leading to unnecessary treatment or false reassurance meets the "risk-of-harm products" criterion at score 3.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling the Solana Bordetella Complete Assay Kit, Model M308, due to a false positive rate of up to 16.7% for Bordetella parapertussis results only. The affected lots include specific lot codes ranging from 245251 through 268479 and above, with various expiration dates. All future lots supplied by QuidelOrtho or its distributors will also be affected until further notice.
The recall affects 952 units that were distributed to medical facilities and one distributor in the United States. Healthcare facilities using this product should review their testing results for Bordetella parapertussis and consider retesting any positive results with an alternative method to confirm accuracy. Patients whose Bordetella parapertussis test results may have been affected should consult with their healthcare providers regarding the reliability of their test findings.
The recalled product
- Product
- Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- false-positive-results
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Code: Catalog number: M308 UDI-DI: 30014613336167
- all future lots
- both supplied by QuidelOrtho or supplied by its distributors
- will be affected.
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighMedtronic DLP One-Piece Pediatric Arterial Cannula Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22