Z-1140-2024Class II

FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal...

Name: Z-1140-2024 FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal...
Creator: BioFire Diagnostics, LLC
Published: 2024-01-26
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2024-01-26 / Open, Classified

FDA source

BioFire Diagnostics, LLC began a recall of FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay... on 2024-01-26. FDA classified it as Class II and gives the reason as "Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1140-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-26
Posted: 2024-02-15
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.
Product code: PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Reason for recall: Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
FDA 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 [email protected] or via telephone at 1-800-735-6544 and select option 5.
Quantity in commerce: 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.
Product codes and lots: Part No.: RFIT-ASY-0116 (30 test kit) UDI-DI code: 00815381020109 Part No. RFIT-ASY-0104 (6 test kit) UDI-DI code: 0081538102011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1140-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1140-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-15

Product code PCH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)