Recall Z-1251-2023 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
BioFire Diagnostics, LLC
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
| Date | Mar 15, 2023 (initiated Feb 1, 2023) |
| Status | Open, Classified |
| Reason | Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays. |
| Root cause | Environmental control |
| Action | On 02/01/2023, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via email to customers informing them of a "Temperature Out of Range" issue with multiple products, as a result from Hurricane Ian (10/2022) Customers are Instructed to: Immediately examine their inventory for product identified in this recall. 1. Discontinue use and discard any remaining product in their possession that is subject to this recall. bioMerieux will replace the product at no charge in accordance with BIOFIRE s standard limited warranty. 2. Complete the accompanying Acknowledgment of Receipt Form and confi |
| Quantity | 2 kits |
| Distribution | U.S. Nationwide distribution in the states of FL and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193519 | BioFire Blood Culture Identification 2 (BCID2) Panel Biofire Diagnostics, LLC, Mar 18, 2020 |