Recall Z-1140-2024
BioFire Diagnostics, LLC · initiated January 26, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
Reason for recall
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1140-2024
- Initiated
- January 26, 2024
- Posted by FDA
- February 15, 2024
- Product code
- PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- 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…
- Recalling firm
- BioFire Diagnostics, LLC, Salt Lake City, UT