---
title: "BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) — FDA record Z-0602-2026 | Is It on Recall"
description: "Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures."
url: https://isitonrecall.com/recall/fda-device-z-0602-2026-biofire-respiratory-panel-2-1-ivd-ref-423742-30-test-kit/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) — FDA record Z-0602-2026

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 Oct 22, 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**: BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
- **Reason**: Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
- **Classification**: Class II
- **Recalling firm**: BioFire Diagnostics, LLC
- **Quantity**: 97 Kits (2,910 pouches)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0602-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0602-2026%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: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725 |

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

## Distribution

US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None

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

- [Arizona](https://isitonrecall.com/state/arizona/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Idaho](https://isitonrecall.com/state/idaho/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New Hampshire](https://isitonrecall.com/state/new-hampshire/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)

## Dates in the source

- **Report date**: Dec 3, 2025
- **Recall initiation date**: Oct 22, 2025
- **Center classification date**: Nov 26, 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-0602-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [BioFire Diagnostics, LLC records](https://isitonrecall.com/brand/biofire-diagnostics-llc/)