CLASS II ONGOING Device recall · Reported 30 Aug 2023 · FDA Enforcement Report

FilmArray Pneumonia Panel (Pneumo) recalled by BioFire Diagnostics

BioFire Diagnostics is recalling FilmArray Pneumonia Panel (Pneumo), distributed in 21 states. The recall was initiated on 8 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPouch Lot # 2NBT22 /Kit # 2187822 ;UDI-DI: UDI: 00815381020482

Quantity recalled24 Kits (30 pouches/kit)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2440-2023
FDA event ID: 92397
Recalling firm: BioFire Diagnostics, Salt Lake City, UT
Classification: Class II
Status: Ongoing
Recall initiated: 8 May 2023
FDA classified: 21 Aug 2023
Reported: 30 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 May 2023	Recall initiated by company
21 Aug 2023	Classified by FDA	+105 days
30 Aug 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to manufacturing issue, panels may result in false negative results.

Product as listed by the FDA

FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only

Where it was distributed

US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia

California Colorado Connecticut Florida Georgia Iowa Illinois Louisiana Massachusetts Michigan Missouri Montana North Carolina Nebraska New Jersey New Mexico New York Pennsylvania Tennessee Utah

Questions about this recall

Why was it recalled?

Due to manufacturing issue, panels may result in false negative results.

Which lots are affected?

Pouch Lot # 2NBT22 /Kit # 2187822 ;UDI-DI: UDI: 00815381020482

Where was it sold?

US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 92397

This product is part of a recall event; the main page for the event is BioFire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics.

Reported	Class	Recall	Company	Reason	Where
30 Aug 2023	CLASS II	BioFire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	21 states

More recalls from BioFire Diagnostics

All 47

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Multiple-type respiratory pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	Multiple-type respiratory pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	Mulitple-type osteoarticular pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide
13 May 2026Device	CLASS II	Biofire Spotfire Respiratory/Sore Throat Panel recalled	BioFire Diagnostics	Device Malfunction	Nationwide

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