The BIOFIRE Respiratory Panel 2 — Class II medical device recall Z-0704-2024
Ongoing recall by BioFire Diagnostics, LLC, reported 2024-01-17, distributed in CA, CT, FL, IA, IL, KS, MA, MD…. A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal
| Recall number | Z-0704-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioFire Diagnostics, LLC, Salt Lake City, UT, United States |
| Recall initiated | 2023-11-27 |
| Classified | 2024-01-10 |
| Reported by FDA | 2024-01-17 |
| Distributed | CA, CT, FL, IA, IL, KS, MA, MD, MO, NC, NE, NJ, OH, TN, TX, UT |
| Quantity | 57 kits |
| UPC / GTIN / UDI-DI | 00815381020529 |
| Lot numbers | 1667923/2X2423, 1890223/2YHT23 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0704-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.