FDA Medical Device Recalls (openFDA)
BioFire Diagnostics, LLC: BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
- Recall number
- Z-2936-2026
- Recalling firm
- BioFire Diagnostics, LLC
- Product
- BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
- Status
- Open, Classified
- Initiated
- 2026-06-24
- Posted
- 2026-08-12
- Terminated
- not on file
- Reason
- Due to increase in false negative results
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QOF
- Firm FEI
- 3002773840
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28