---
title: "Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella... — FDA record Z-1948-2025 | Is It on Recall"
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 (onl"
url: https://isitonrecall.com/recall/fda-device-z-1948-2025-brand-name-solana-bordetella-complete-assay-product-name-solana-bordetella-kit-model-catalog-number/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software... — FDA record Z-1948-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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.
- **Classification**: Class II
- **Recalling firm**: Ortho-Clinical Diagnostics, Inc.
- **Quantity**: 952 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1948-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1948-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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. |

Match all identifying details in the current notice. A brand name alone is not enough.

## 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. QuidelOrtho sent the notification to their consignees because QuidelOrtho drop-shipped this product to their 31 consignees (Included in the Medical Facility total below).

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Jun 18, 2025
- **Recall initiation date**: Mar 24, 2025
- **Center classification date**: Jun 11, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1948-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Ortho-Clinical Diagnostics, Inc. records](https://isitonrecall.com/brand/ortho-clinical-diagnostics-inc/)