CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report

BioFire Joint Infection (JI) Panel recalled by BioFire Diagnostics

BioFire Diagnostics is recalling BioFire Joint Infection (JI) Panel, distributed nationwide in the US. The recall was initiated on 22 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #s:0883425,0878825/DI: 00815381020192

Quantity recalled106 kits (3,180 test)

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-2067-2026
FDA event ID: 98776
Recalling firm: BioFire Diagnostics, Salt Lake City, UT
Classification: Class II
Status: Ongoing
Recall initiated: 22 Apr 2026
FDA classified: 6 May 2026
Reported: 13 May 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

22 Apr 2026	Recall initiated by company
6 May 2026	Classified by FDA	+14 days
13 May 2026	Published in enforcement report	+7 days

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

Reason for recall

Contamination to in-vitro diagnostic test may result in false positives.

Product as listed by the FDA

BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

Where it was distributed

Worldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the countries of France, Italy, Germany, Spain, Belgium, Switzerland, United Kingdom, Netherlands, Poland, Austria, India, Finland, Czech Republic, Egypt, Lebanon, Morocco, Slovenia, Romania, Dominican Republic, Serbia.

Nationwide Maryland North Carolina Texas Utah

Questions about this recall

Why was it recalled?

Contamination to in-vitro diagnostic test may result in false positives.

Which lots are affected?

Lot #s:0883425,0878825/DI: 00815381020192

Where was it sold?

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.

More recalls from BioFire Diagnostics

All 44

Reported	Class	Recall	Company	Reason	Where
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
3 Dec 2025Device	CLASS II	BioFire Respiratory Panel 2.1, IVD recalled by BioFire Diagnostics	BioFire Diagnostics	Device Malfunction	10 states
4 Jun 2025Device	CLASS II	BioFire Respiratory Panel 2.1 plus Kit recalled by BioFire Diagnostics	BioFire Diagnostics	Device Malfunction	UT
16 Apr 2025Device	CLASS II	FilmArra Pneumonia Panel plus (Pneumoplus) recalled	BioFire Diagnostics	Device Malfunction	UT

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