Brand Name: Solana Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Ver

FDA device recall Z-1948-2025 · posted 2025-06-11 · Open, Classified

Recall details

Recalling firm

Ortho-Clinical Diagnostics, Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OZZ

Quantity affected

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 af

Date initiated

2025-03-24

Date posted

2025-06-11

Location

Rochester, NY

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