BioFire FilmArray Meningitis/Encephalitis Panel Recalled for False Positive Risk
BioFire Diagnostics is recalling specific FilmArray Meningitis/Encephalitis (ME) Panel kits due to a manufacturing issue that may cause elevated rates of false positive results for HSV-1.
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. The hazard involves a risk of false positive results, which is a diagnostic accuracy issue rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
BioFire Diagnostics, LLC is recalling 1,350 pouches of the FilmArray Meningitis/Encephalitis (ME) Panel (REF RFIT-ASY-0118). The recall affects specific kits with lot numbers 580818 and 584418, which contain pouches with lot numbers 892018 and 896018, respectively. These kits have expiration dates of April 2, 2019, and April 5, 2019.
The firm identified an issue in the manufacturing process that might contribute to elevated rates of false positive results for HSV-1 (Herpes Simplex Virus type 1) when using the ME Panel. The affected kits contain a Primer Pill (Lot 210318), which is a freeze-dried pellet containing primers and buffer used in the PCR reaction.
The affected products were distributed worldwide, including nationwide in the United States (specifically in CA, DC, FL, IN, KY, MN, MO, NB, NJ, OH, TX, and WI) and internationally in Canada, Colombia, and Mexico. Users should stop using the affected kits and contact BioFire Diagnostics for further instructions.
The recalled product
- Product
- -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray¿ ME Panel v1.4…
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 1,350
Distribution
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