Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0148-2027·Announced 2026-10-21

BioFire FilmArray Pneumonia Panel Recalled for Potential Contamination

BioFire Diagnostics is recalling specific lots of FilmArray Pneumonia Panels due to potential contamination that could result in false positive test 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 that could result in false positive test results. The source does not report any illnesses, injuries, or deaths.

Plain-English summary

BioFire Diagnostics, LLC is recalling specific lots of the FilmArray Pneumonia Panel, a multiple-type respiratory pathogen nucleic acid in vitro diagnostic (IVD) kit. The recall involves 4,892 units, including 30-pack and 6-pack configurations as well as Verification Kits. The affected products are identified by specific UDI numbers and a list of lot numbers provided in the recall documentation.

The recall was initiated due to potential contamination of specific lots of pneumonia and joint infection panels. This contamination could result in false positive results when the tests are used. The source text does not report any illnesses, injuries, or deaths associated with this recall.

The affected products were distributed worldwide, including nationwide distribution across all U.S. states and territories, as well as to numerous international countries. Users of these diagnostic kits should stop using the affected lots and contact BioFire Diagnostics for further instructions or a replacement.

The recalled product

Product: Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from…
Manufacturer: BioFire Diagnostics, LLC
Category: Medical Device — In Vitro Diagnostics
Hazard: contamination
false-positive-results
Affected units: 4,892

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 00815381020178 (30 pack)
00815381020185 (6 pack)
Model Nos RFIT-PRT-0144 (30 pack)
RFIT-ASY-0145 (6 pack)
FLM1-ASY-0150 (Verification Kit)
Lot Numbers 0638726
0676626
0676726
0716526
0727826
0767926
0804526
0804626
0860926
0882826
0882926
0883026
0914626
0914726
0914826

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Same manufacturer · BioFire Diagnostics, LLC

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