---
title: "The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic ... — FDA record Z-0704-2024 | Is It on Recall"
description: "A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to i"
url: https://isitonrecall.com/recall/fda-device-z-0704-2024-the-biofire-respiratory-panel-2-1-rp2-1-is-a-pcr-based-multiplexed-nucleic-acid-test-intended-for-us/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOF... — FDA record Z-0704-2024

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 27, 2023. 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**: The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.
- **Reason**: A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.
- **Classification**: Class II
- **Recalling firm**: BioFire Diagnostics, LLC
- **Quantity**: 57 Kits
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0704-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0704-2024%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: 00815381020529. Kit Lot/Pouch Lot/Expiration: 1667923/2X2423/June 26, 2024; 1890223/2YHT23/July 26, 2024 |

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

## Distribution

US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD

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

- [California](https://isitonrecall.com/state/california/)
- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Iowa](https://isitonrecall.com/state/iowa/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Kansas](https://isitonrecall.com/state/kansas/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [Missouri](https://isitonrecall.com/state/missouri/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [Nebraska](https://isitonrecall.com/state/nebraska/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Utah](https://isitonrecall.com/state/utah/)

## Dates in the source

- **Report date**: Jan 17, 2024
- **Recall initiation date**: Nov 27, 2023
- **Center classification date**: Jan 10, 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-0704-2024%22)

## Related records

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