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.
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: 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
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