Z-2936-2026Class II

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

Name: Z-2936-2026 BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid...
Creator: BioFire Diagnostics, LLC
Published: 2026-06-24
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2026-06-24 / Open, Classified

FDA source

BioFire Diagnostics, LLC began a recall of BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic on 2026-06-24. FDA classified it as Class II and gives the reason as "Due to increase in false negative results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2936-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-24
Posted: 2026-08-12
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
Product code: QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Reason for recall: Due to increase in false negative results
FDA 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 [email protected].
Quantity in commerce: 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.
Product codes and lots: Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2936-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2936-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-12

Product code QOF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)