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Ortho-Clinical Diagnostics, Inc. recalls Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software
Recalled June 18, 2025 · FDA recall Z-1948-2025 · Ortho-Clinical Diagnostics
Hazard
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. · FDA Class II
Units
952 units
Sold at
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).
Description
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.
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
Manufacturer(s)
Ortho-Clinical Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →