CLASS II ONGOING Device recall · Reported 21 Feb 2024 · FDA Enforcement Report

FilmArray Gastrointestinal (GI) Panel Rfit-asy recalled

BioFire Diagnostics is recalling FilmArray Gastrointestinal (GI) Panel Rfit-asy-0116 (30 test kit) Rfit-asy-0104 (6 test, distributed nationwide in the US. The recall was initiated on 26 Jan 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart No.: RFIT-ASY-0116 (30 test kit) UDI-DI code: 00815381020109 Part No. RFIT-ASY-0104 (6 test kit) UDI-DI code: 0081538102011

Quantity recalled64,594 kits (equals 2,303,760 tests)

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-1140-2024
FDA event ID: 93639
Recalling firm: BioFire Diagnostics, Salt Lake City, UT
Classification: Class II
Status: Ongoing
Recall initiated: 26 Jan 2024
FDA classified: 15 Feb 2024
Reported: 21 Feb 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Norovirus
Device type: Test Kits & Diagnostics

Timeline

26 Jan 2024	Recall initiated by company
15 Feb 2024	Classified by FDA	+20 days
21 Feb 2024	Published in enforcement report	+6 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 potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.

Product as listed by the FDA

FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.

Where it was distributed

Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, US Virgin Island, VT, WA, WI, WV, and WY. The countries of Andorra, United Arab Emirates, Albania, Armenia, Argentina, Austria, Australia, Bosnia, Belgium, Bulgaria, Bahrain, Bermuda, Bolivia, Brazil, Botswana, Canada, Congo, Switzerland, Cote D'Ivoire, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, Fiji, France, United Kingdom, Georgia, French Guiana, Gibraltar, Guadeloupe, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Iceland, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Korea, Kuwait, Lebanon, Lithuania, Latvia, Morocco, Macedonia, Mali, Myanmar, Mongolia, Macau, Mauritania, Mexico, Malaysia, Namibia, New Caledonia, Nigeria, Nicaragua, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, French Polynesia, Papua New Guinea, Philippines, Poland, St. Pierre/Miquelon, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, El Salvador, Thailand, Tunisia, Turkey, Taiwan, Uganda, Uruguay, Vatican City, Venezuela, Vietnam, South Africa, and Zimbabwe.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.

Which lots are affected?

Part No.: RFIT-ASY-0116 (30 test kit) UDI-DI code: 00815381020109 Part No. RFIT-ASY-0104 (6 test kit) UDI-DI code: 0081538102011

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.

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