BIOFIRE Respiratory Panel 2.1 recalled for false negative manufacturing defect
BioFire Diagnostics recalls 57 kits of the BIOFIRE Respiratory Panel 2.1 due to a manufacturing defect that may produce false negative results, potentially causing treatment delays or missing infections.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II diagnostic device with a manufacturing defect causing false negative results. No illnesses or deaths are reported. However, this is a risk-of-harm product where diagnostic errors directly threaten patient care through missed diagnoses, delayed treatment, and disease spread. Per the rubric, risk-of-harm products without reported injury score 3.
Plain-English summary
BioFire Diagnostics, LLC is recalling 57 kits of the BIOFIRE Respiratory Panel 2.1 (RP2.1), a PCR-based diagnostic test used with BIOFIRE FILMARRAY 2.0 or Torch Systems.
A manufacturing event may cause elevated rates of false negative results. Patients with respiratory or gastrointestinal infections could receive negative test results, leading to no treatment, inappropriate treatment, or delayed treatment. False negatives also create false assurance that patients are infection-free, delaying outbreak identification and potentially increasing disease spread.
The affected kits were distributed to 16 US states: North Carolina, Missouri, Nebraska, Connecticut, Illinois, Tennessee, New Jersey, Ohio, Massachusetts, California, Florida, Utah, Iowa, Kansas, Texas, and Maryland. Two lot numbers are identified: 1667923 (expiration June 26, 2024) and 1890223 (expiration July 26, 2024).
If you used an affected kit for testing, consult your healthcare provider to discuss potential retesting or clinical follow-up if you have respiratory or gastrointestinal symptoms.
The recalled product
- Product
- The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.
- Manufacturer
- BioFire Diagnostics, LLC
- Category
- Medical Device — Diagnostic Test
- Affected units
- 57
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 00815381020529. Kit Lot/Pouch Lot/Expiration: 1667923/2X2423/June 26
- 2024
- 1890223/2YHT23/July 26
Distribution
Part of a larger recall action
This product is one of 2 recalled by BioFire Diagnostics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · BioFire Diagnostics, LLC
See all →- HighBioFire Respiratory Panel 2.1 Recalled for Increased False Negative Results
FDA (Devices) · 2026-08-19
- HighBioFire Joint Infection Panel diagnostic test kit contamination recall
FDA (Devices) · 2026-05-13
- HighBioFire Spotfire Respiratory/Sore Throat Panel Recall for False Negatives
FDA (Devices) · 2026-05-13
- HighRespiratory test panels recalled over elevated risk of false negative results
FDA (Devices) · 2025-12-03
- HighBioFire Respiratory Panel 2.1 plus Kit recalled for manufacturing defect
FDA (Devices) · 2025-06-04
Same hazard · false negative
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighHologic Aptima HPV assay may produce invalid or false negative results
FDA (Devices) · 2026-03-25
- HighHeparin antibody test kits recalled over a defect producing negative results
FDA (Drugs) · 2026-01-21