BioFire FilmArray Gastrointestinal Panel Recalled for False Positive Results
BioFire Diagnostics is recalling the FilmArray Gastrointestinal (GI) Panel due to elevated rates of false positive results for Campylobacter and Cryptosporidium.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to false positive results without reports of direct physical injury or death, fitting the criteria for a moderate severity issue.
Plain-English summary
BioFire Diagnostics, LLC is recalling the FilmArray Gastrointestinal (GI) Panel, an in vitro diagnostic (IVD) test intended for use with FilmArray systems. The recall affects 17,188 units distributed worldwide, including nationwide in the United States and in numerous foreign countries.
The recall was initiated because elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified. The affected lots have an expiration date of 23 October 2019 onward.
Healthcare providers and laboratories should stop using the affected products and contact BioFire Diagnostics for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with…
- Manufacturer
- BioFire Diagnostics, LLC
- Hazard
- Affected units
- 17,188
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)
- Lots with an expiration date of 23 October 2019 onward
Distribution
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