Ortho-Clinical Diagnostics, Inc. recalls Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software V…

Recall date

March 24, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1948-2025

FDA classification

Class II

Brand / firm

Ortho-Clinical Diagnostics, Inc.

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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