Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0149-2027·Announced 2026-10-21

BioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination

BioFire Diagnostics is recalling specific lots of FilmArray Pneumonia Panel Plus kits due to potential contamination that could cause false positive results.

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 Class II due to potential contamination causing false positive results, which may lead to temporary or medically reversible adverse health consequences. The source does not report any illnesses, injuries, or deaths.

Plain-English summary

BioFire Diagnostics, LLC is recalling 3,871 units of the FilmArray Pneumonia Panel Plus in vitro diagnostic (IVD) kits. The affected models are RFIT-ASY-0143 (30 Kit) and RFIT-ASY-0142 (6 Kit). The recall is due to potential contamination of specific lots, which could result in false positive test results.

The affected products were distributed nationwide in the United States and in numerous countries worldwide, including Canada, the United Kingdom, Germany, and Japan. Specific lot numbers and UDI numbers for the affected kits are listed in the agency's recall record.

Healthcare facilities and consumers should stop using the affected lots immediately and contact BioFire Diagnostics for instructions on how to return the product or obtain a replacement. The source text does not report any illnesses, injuries, or deaths associated with this recall.

The recalled product

Product: Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid…
Manufacturer: BioFire Diagnostics, LLC
Category: Medical Device — In Vitro Diagnostics
Hazard: contamination
false-positive
Affected units: 3,871

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 (20)

Lot Code: UDI Nos 00815381020314 (30 Kit)
00815381020321 (6 Kit)
Model Nos RFIT-ASY-0143 (30 Kit)
RFIT-ASY-0142 (6 Kit)
Lot Numbers 0638426
0638526
0676426
0676526
0679726
0804826
0804926
0805026
0883126
0922126
0941426
0941526
0997926
0998026
1020626
1020726

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Same manufacturer · BioFire Diagnostics, LLC

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