BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 recallZ-2936-2026 · BioFire Diagnostics, LLC · initiated Jun 24, 2026

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from BioFire Diagnostics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to increase in false negative results

FDA root cause category: Under Investigation by firm

What the company is doing

On 06/24/2026, an "URGENT MEDICAL DEVICE CORRECTION" Letter was emailed to customers informing them that bioMrieux received complaints of false-negative results associated with BIOFIRE RP2.1 kit lot 1872125 / pouch lot 3VLB25. An internal investigation confirmed the presence of incorrect PCR1 primers in a subset of pouches within BIOFIRE RP2.1 kit lot 1872125 introduced during reagent manufacturing. This field safety notice was issued because the incorrect PCR1 primers will lead to pouch pathogen assay negative results with passing control assays. Customers are instructed to: "Examine your inventory for the lot identified in this field safety notice. "Cease use and discard any remaining product from this lot in your possession. "Confirm the quantity of kits that have been destroyed, previously used, or returned on the attached Acknowledgement of Receipt Form. "If you have further distributed this product, please identify any recipients and notify them at once. "Complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification. "bioMerieux will be providing pouch credit for affected products. For Questions - contact local Customer Service Representative at (800) 682-2666. For non-urgent inquiries, contact the Technical Support Center by email at [email protected].

Recall details

Recall number: Z-2936-2026
Status: Open, Classified
Initiated by the company: Jun 24, 2026
Posted by the FDA: Aug 12, 2026
Recalling firm: BioFire Diagnostics, LLC
Quantity: 2,370 pouches (79 kits)
Product code: QOF
Distribution: U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.

Product description

BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic

Code information (models, lots, serial numbers)

Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

BioFire® Respiratory Panel 2.1 423742
Biofire Diagnostics, LLC · Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
3 recalls4 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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