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U.S. Department of Health and Human Services

Class 2 Device Recall BIOFIRE Respiratory Panel 2.1 (RP2.1)

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 Class 2 Device Recall BIOFIRE Respiratory Panel 2.1 (RP2.1)see related information
Date Initiated by FirmJune 24, 2026
Date PostedAugust 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2936-2026
Recall Event ID 99261
Product Classification Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents - Product Code QOF
ProductBIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Code Information Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
FEI Number 3002773840
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information ContactCustomer Support Department
800-682-2666 Ext. 360
Manufacturer Reason
for Recall		Due to increase in false negative results
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 in Commerce2,370 pouches (79 kits)
DistributionU.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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