Recall archive / FDA device enforcement
Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software... — FDA record Z-1948-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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 48 Reaction Tubes. Component: No, not a component
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 952 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1948-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Code: Catalog number: M308 UDI-DI: 30014613336167; Lots: 245251 - 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 Lots: 265007-1 - 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Please see the attached list "Consignee List_CL2025-120." Note: This file contains a specific tab, titled Shipping Summary, which contains the US and ex-US shipping summary. One (1) Distributor was affected. The other four(4) Distributors were sent the notification for information only. QuidelOrtho sent the notification to their consignees because QuidelOrtho drop-shipped this product to their 31 consignees (Included in the Medical Facility total below).
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jun 18, 2025
- Recall initiation date
- Mar 24, 2025
- Center classification date
- Jun 11, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.