CLASS II ONGOING Device recall · Reported 26 Apr 2023 · FDA Enforcement Report

FilmArray Gastrointestinal (GI) Panel for Filmarray Systems recalled

BioFire Diagnostics is recalling FilmArray Gastrointestinal (GI) Panel for Filmarray Systems, distributed nationwide in the US. The recall was initiated on 8 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPouch Lot# 2N3R22 / Kit Lot# 2160422; UDI-DI: (00)815381020109

Quantity recalled900 pouches (30 kits)

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-1392-2023
FDA event ID: 91892
Recalling firm: BioFire Diagnostics, Salt Lake City, UT
Classification: Class II
Status: Ongoing
Recall initiated: 8 Mar 2023
FDA classified: 14 Apr 2023
Reported: 26 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Mar 2023	Recall initiated by company
14 Apr 2023	Classified by FDA	+37 days
26 Apr 2023	Published in enforcement report	+12 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, Gastrointestinal (GI) Panel may result in false negative results.

Product as listed by the FDA

FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

Where it was distributed

US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.

Nationwide Arkansas California District of Columbia Illinois Kansas Louisiana Minnesota North Carolina New York Oklahoma Wisconsin

Questions about this recall

Is FilmArray Gastrointestinal (GI) Panel for Filmarray Systems recalled?

Yes. BioFire Diagnostics recalled FilmArray Gastrointestinal (GI) Panel for Filmarray Systems on 8 Mar 2023. The recall is Class II and its status is Ongoing. Recall number Z-1392-2023.

Why was it recalled?

Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.

Which lots are affected?

Pouch Lot# 2N3R22 / Kit Lot# 2160422; UDI-DI: (00)815381020109

Where was it sold?

US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.

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

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