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

FDA device recall Z-2936-2026 · posted 2026-08-12 · Open, Classified

Recall details

Recalling firm

BioFire Diagnostics, LLC

Reason for recall

Due to increase in false negative results

Action taken

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 biofiresupport@biomerieux.com.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

QOF

Quantity affected

2,370 pouches (79 kits)

Distribution

U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.

Date initiated

2026-06-24

Date posted

2026-08-12

Location

Salt Lake City, UT