FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorgan
FDA device recall Z-1140-2024 · posted 2024-02-15 · Open, Classified
Recall details
- Recalling firm
- BioFire Diagnostics, LLC
- Reason for recall
- Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- PCH
- Quantity affected
- 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,
- Date initiated
- 2024-01-26
- Date posted
- 2024-02-15
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K230404) | Biofire Diagnostics, LLC | 2023-03-16 |
| FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch (K160459) | Biofire Diagnostics, LLC | 2016-04-01 |
| FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 (K143005) | Biofire Diagnostics, LLC | 2015-02-19 |
| FILMARRAY GASTROINTESTINAL (GI) PANEL (K140407) | Biofire Diagnostics | 2014-05-02 |