BioFire Diagnostics recall: BIOFIRE Respiratory Panel 2.1
BioFire Diagnostics, LLC is recalling BIOFIRE Respiratory Panel 2.1 – 2,370 pouches (79 kits). The U.S. Food and Drug Administration published the recall on August 19, 2026; it began on June 24, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | BIOFIRE Respiratory Panel 2.1 |
| Brand | BioFire Diagnostics |
| Company | BioFire Diagnostics, LLC |
| Type | Medical devices |
| Classification | Class II |
| Recall date | June 24, 2026 |
| Published by FDA | August 19, 2026 |
| Quantity | 2,370 pouches (79 kits) |
| Recall ID | 99261 |
Recalled products
- BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
- FDA recall number
- Z-2936-2026
- Codes, lots and dates
- Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
- Quantity
- 2,370 pouches (79 kits)
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99261
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Salt Lake City, UT, United States
Why it was recalled
The reason the FDA lists: “Due to increase in false negative results”
Where it was sold
Nationwide. Distribution as the FDA records it: “U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99261, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is BioFire Diagnostics BIOFIRE Respiratory Panel 2.1 recalled?
Yes. BioFire Diagnostics, LLC recalled it on June 24, 2026; FDA published it August 19, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Due to increase in false negative results
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.