Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana… — Class II medical device recall Z-1948-2025
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2025-06-18. It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated wi
| Recall number | Z-1948-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc., Rochester, NY, United States |
| Recall initiated | 2025-03-24 |
| Classified | 2025-06-11 |
| Reported by FDA | 2025-06-18 |
| Quantity | 952 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 30014613336167 |
| Lot numbers | 2025-DEC-03, 2025-OCT-25, 2026-DEC-11, 2026-DEC-31, 2026-FEB-06, 2026-NOV-22, 2026-OCT-02, 2026-OCT-23, 2026-SEP-03, 2027-JAN-03, 245251, 246941, 250163, 259686, 261072, 262113, 263331, 264065, 265007, 265007-1, 268479 |
| Model numbers | M308 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1948-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.