BioFire Spotfire Respiratory/Sore Throat Panel Recall for False Negatives
BioFire Diagnostics, LLC is recalling the Spotfire Respiratory/Sore Throat Panel due to false negative test results and control failures that may not accurately detect infections.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall involving a diagnostic medical device with risk of false negatives—a high-risk condition that could lead to missed diagnosis of infections. Although no reported illnesses or injuries are stated in the source, the nature of the hazard (inaccurate diagnostic results) poses significant risk of patient harm by failing to detect infections that require treatment.
Plain-English summary
BioFire Diagnostics, LLC is recalling the Spotfire Respiratory/Sore Throat Panel (REF: 423485), a diagnostic test used to detect respiratory and sore throat infections. The panel may produce false negative results and control failures, potentially failing to accurately identify infections that are present.
Approximately 2,400 pouches have been distributed nationwide, including to patients and healthcare providers in Mississippi, Texas, Minnesota, and Virginia. The affected lot number is 2215125 (UDI: 00815381020390).
Patients and healthcare providers who have used or received this test should contact BioFire Diagnostics, LLC for instructions on return or replacement. Healthcare providers should review patient results for accuracy and consider retesting if clinically appropriate.
The recalled product
- Product
- Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 2,400
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 (1)
- Lot Number: 2215125/UDI: 00815381020390
Distribution
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