Recall Z-1948-2025 ยท OZZ Bordetella Pertussis Dna Assay System
Ortho-Clinical Diagnostics, Inc.
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
| Date | Jun 11, 2025 (initiated Mar 24, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On May 6, 2025, URGENT PRODUCT CORRECTION NOTIFICATION letters to customers. REQUIRED ACTION " Do not report Bordetella parapertussis (BPP) positive results when testing with the affected lot numbers. " Use the Solana Bordetella Complete Assay only for reporting Bordetella pertussis (BP) results and negative Bordetella parapertussis (BPP) results only when using the affected lots, as they are not affected. " Review the content of this communication with your Medical Director and retain this letter for your laboratory. " Complete the enclosed Confirmation of Receipt form no later than May 14, 2 |
| Quantity | 952 units |
| 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. Quide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181029 | Solana Bordetella Complete Assay Quidel Corporation, Jul 15, 2018 |