Reported Jun 18, 2025 · Ongoing
Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software…
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, Inc. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- Brand NameSolana¿
- Bordetella Complete Assay Product NameSolana
- Bordetella kit Model/Catalog NumberM308
- Software Versionnot
- applicable Product DescriptionOne sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and 48 Reaction Tubes
- ComponentNo, not a component
- Lot codes and dates
- Lot CodeCatalog
- numberM308
- UDI-DI30014613336167
- Lots245251 - Exp. 2025-Oct-25 246941 - Exp. 2025-Dec-03 250163 - Exp. 2026-Feb-06 259686 - Exp. 2026-Sep-03 261072 - Exp. 2026-Oct-02 262113 - Exp. 2026-Oct-23 263331 - Exp. 2026-Nov-22 264065 - Exp. 2026-Dec-11 265007 - Exp. 2027-Jan-03 (corrected exp date from 2026-Dec-31) 266928 - Exp. 2026-Dec-31
- Additional Lots265007-1 - Exp. 2026-Dec-31 268479 and above - Various Expiration dates *Until further notice, all future lots, both supplied by QuidelOrtho or supplied by its distributors, will be affected
- Amount recalled
- 952 units
Why it was recalled
It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.
This product could cause temporary or reversible health problems — stop using it.
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