BioFire Diagnostics, LLC: 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.

Recall number

Z-1140-2024

Recalling firm

BioFire Diagnostics, LLC

Product

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.

Status

Open, Classified

Initiated

2024-01-26

Posted

2024-02-15

Terminated

not on file

Reason

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

Root cause

Under Investigation by firm

Action

On 01/262024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via overnight FedEx to customers to inform them of the increased risk of false positive Norovirus results when the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel. Customers are requested to take the following actions: In this context, we request you to take the following actions. Please: - Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. - If a positive Norovirus result is inconsistent with clinical presentation, the positive Norovirus result should be confirmed using another method. - Complete the Acknowledgement Form in Attachment A (on the following page) and return it to bioMerieux to confirm receipt of this notice. It is important that you return the acknowledgement form to bioMerieux even if you determine that this urgent product correction notice does not impact your facility. For questions/assistance contact BIOFIRE Technical Support Team at biofiresupport@biomerieux.com or via telephone at 1-800-735-6544 and select option 5.

Quantity

64,594 kits (equals 2,303,760 tests)

Distribution

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.

Lot, serial or model codes

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

510(k) numbers

["K140407","K143005","K160459","K230404"]

PMA numbers

not on file

Product code

PCH

Firm FEI

3002773840

Firm city

Salt Lake City

Firm state

UT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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