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
- Hazard
- false-negative
- delayed-treatment
- diagnostic-error
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
Distributed in 16 states:
- CA
- CT
- FL
- IA
- IL
- KS
- MA
- MD
- MO
- NC
- NE
- NJ
- OH
- TN
- TX
- UT
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