---
title: "Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 — FDA record Z-0694-2025 | Is It on Recall"
description: "SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results."
url: https://isitonrecall.com/recall/fda-device-z-0694-2025-panther-fusion-sars-cov-2-flu-a-b-rsv-assay-ref-prd-07400/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 — FDA record Z-0694-2025

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 Nov 8, 2024. 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**: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
- **Reason**: SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
- **Classification**: Class II
- **Recalling firm**: Hologic, Inc.
- **Quantity**: 3
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0694-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0694-2025%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 | UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494 |

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

## Distribution

US: AK

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alaska](https://isitonrecall.com/state/alaska/)

## Dates in the source

- **Report date**: Jan 1, 2025
- **Recall initiation date**: Nov 8, 2024
- **Center classification date**: Dec 20, 2024

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-0694-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Hologic, Inc records](https://isitonrecall.com/brand/hologic-inc/)