Recall Z-1392-2023 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
BioFire Diagnostics, LLC
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
| Date | Apr 14, 2023 (initiated Mar 8, 2023) |
| Status | Open, Classified |
| Reason | Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results. |
| Root cause | Under Investigation by firm |
| Action | On March 8, 2023, Biomerieux ( Parent company of BioFire Diagnostics, LLC) issued an "Urgent: Medical Device Correction" notification to affected consignees via E-Mail. In addition, to notifying affected consignees about the recalled device, Biomerieux asked consignees to take the following actions: 1. Immediately examine your inventory for product identified in this recall (refer to Table 1). 2. Discontinue use and discard any remaining product in your possession that is subject to this recall. bioMerieux will replace the product at no charge in accordance with BIOFIRE s standard limited w |
| Quantity | 900 pouches (30 kits) |
| Distribution | US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI. |
| FDA record | Open on fda.gov |