FilmArray® Pneumonia Panel plus (Pneumoplus) RFIT-ASY-0142Recalls & reported problems

Biofire Diagnostics, LLC · IVD reagent kit containing 6 tests · Class 2

All models of FilmArray Pneumonia Panel plus (Pneumoplus) (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K181324, K222601, K243222); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Aug 12, 2026Open, Classified
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
Z-0149-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181324, K222601, K243222. One submission often covers many models, so check the product and lot details in each record.

Z-0148-2027 · Aug 12, 2026 · Open, Classified
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
Z-1518-2025 · Feb 27, 2025 · Open, Classified
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Z-0993-2024 · Dec 14, 2023 · Open, Classified
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
Z-2040-2021 · Jun 7, 2021 · Terminated
FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)

Device details

UDI-DI	`00815381020321`
Brand	FilmArray® Pneumonia Panel plus (Pneumoplus)
Model	RFIT-ASY-0142
Company	Biofire Diagnostics, LLC
Product code	QDS · Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
Class	Class 2
FDA submission	K181324, K222601, K243222
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 6, 2025

Device type (GMDN): Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (bacteria, fungi and/or viruses) associated with respiratory disease in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, influenza A, respiratory syncytial viruses A and B, rhinovirus, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, and/or enterovirus.

Other Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System devices

FilmArray® Pneumonia Panel plus (Pneumoplus) RFIT-ASY-0143
Biofire Diagnostics, LLC · Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
4 recalls3 deaths4 reports

All Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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