Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308…

Date

June 18, 2025

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Ortho-Clinical Diagnostics, Inc.

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.

Distribution pattern

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).

Quantity

952 units

Codes and lots

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.

Recall started

March 24, 2025

Device type

Bordetella Pertussis Dna Assay System

Root cause (FDA)

Under Investigation by firm

What the company told customers

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, 2025. Contact Information We apologize for the inconvenience this will cause your laboratory. If you have further questions, please contact our Global Services Organization at 1-800-874-1517 or technicalsupport@quidelortho.com.

Recall number

Z-1948-2025

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1948-2025. The agency record governs; check it and the company before acting.