BioFire FilmArray GI Panel Recalled for Potential False Negative Results
BioFire Diagnostics is recalling FilmArray Gastrointestinal Panel test kits due to a manufacturing issue that may produce false negative results. Affected units may fail to detect gastrointestinal 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 a Class II FDA medical device recall for a diagnostic test that may produce false negative results. No illnesses, injuries, or hospitalizations are reported, and the hazard is theoretical. Per the rubric, this qualifies as High severity under the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
BioFire Diagnostics, LLC is recalling 900 pouches (30 kits) of FilmArray Gastrointestinal (GI) Panel, model RFIT-ASY-0116, due to a manufacturing issue. The affected units are identified by Pouch Lot# 2N3R22 and Kit Lot# 2160422 (UDI-DI: (00)815381020109).
The manufacturing issue may cause the test panels to produce false negative results. This means that the test may fail to detect gastrointestinal infections when they are present.
The product was distributed nationwide to healthcare facilities and laboratories in Arkansas, California, the District of Columbia, Illinois, Kansas, Louisiana, Minnesota, North Carolina, New York, Oklahoma, and Wisconsin.
Patients who may have been tested using affected test kits should consult with their healthcare provider about the potential for a false negative result. Healthcare providers should immediately stop using product from affected lots and contact BioFire Diagnostics for information about obtaining replacement product.
The recalled product
- Product
- FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
- Manufacturer
- BioFire Diagnostics, LLC
- Category
- Medical Device — Diagnostics
- Hazard
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 (2)
- Pouch Lot# 2N3R22 / Kit Lot# 2160422
- UDI-DI: (00)815381020109
Distribution
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