BioFire FilmArray Gastrointestinal Panel Recalled for False Negative Results
BioFire Diagnostics is recalling FilmArray Gastrointestinal Panel kits due to elevated false negative rates that may lead to incorrect treatment.
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: The recall is classified as FDA Class II. The hazard involves false negative results leading to incorrect treatment, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
BioFire Diagnostics, LLC is recalling 23 kits (690 pouches) of the FilmArray Gastrointestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit. The affected product has UDI (01)00815381020116 and is labeled CE IVD, Rx Only. The specific lot numbers are Kit Lot 0537319 and Pouch Lot 681619, with a pouch expiration date of May 30, 2020.
The recall was initiated after complaints were received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided, which could potentially lead to more serious health events.
The affected kits were distributed in Kentucky, Illinois, New Jersey, and Mississippi. Consumers and healthcare providers should stop using the affected kits and contact BioFire Diagnostics for further instructions.
The recalled product
- Product
- FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
- Manufacturer
- BioFire Diagnostics, LLC
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)
- Kit Lot: 0537319 / Pouch Lot: 681619 Pouch Lot Date of Expiration 2020-05-30
Distribution
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 Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recalled 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
Similar recalls
- HighBioFire FilmArray GI Panel Recalled for Potential False Negative Results
FDA (Devices) · 2023-04-26
- ModerateBioFire FilmArray Gastrointestinal Panel Recalled for False Positive Results
FDA (Devices) · 2019-05-08
- HighDiagnostic Test Kits for GI Panel May Return False Negatives Due to Manufacturing Issue
FDA (Devices) · 2024-01-17
- HighDiagnostic Test Kits Recalled for False Vibrio Results With Certain Transport Medium
FDA (Devices) · 2024-08-14
- HighFilmArray GI diagnostic kits recalled due to false positive Norovirus results
FDA (Devices) · 2024-02-21
- HighFILMARRAY GI Panel Software Recalled for False Positive Cryptosporidium Results
FDA (Devices) · 2023-09-20