Recall Z-1451-2020 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
BioFire Diagnostics, LLC
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
| Date | Aug 8, 2019 |
| Status | Terminated |
| Reason | Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events. |
| Root cause | Employee error |
| Action | on August 8, 2019, a "Urgent: Medical Device Recall (Removal)" letter was sent to all affected consignees via FedEx priority-overnight. The notification informed consignees about the recall and asked they take the following actions: Requested Actions: " Please immediately examine your inventory for BioFire GI Panel reagents with kit lot number 0537319. The lot number can be found on the product label outside of the reagent box. " If reagents with the related kit lot number are found, please stop using the affected product, quarantine them, and call BioFire Technical Support to have the prod |
| Quantity | 23 kits (690 pouches) |
| Distribution | US: KY, IL, NJ, MS |
| FDA record | Open on fda.gov |