FDA Device recall Z-1948-2025
Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicab…
- FDA Device
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicab… by Ortho Clinical Diagnostics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1948-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-24 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | n/a |
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.
Identifiers
| code_info | Lot Code: Catalog number: M308 UDI-DI: 30014613336167; Lots: 245251 - Exp. 2025-Oct-25 246941 - Exp. 2025-Dec-03 25016…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1948-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.