Recall Z-1903-2021 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
BioFire Diagnostics, LLC
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
| Date | May 10, 2021 |
| Status | Terminated |
| Reason | Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel. |
| Root cause | Process control |
| Action | On 5/10/21, BioFire distributed a "Urgent: Medical Device Correction" letter to all consignees via: E-Mail. In addition to providing consignees with a recall notification, the firm ask consignees to take the following actions: 1 Immediately examine your inventory for product identified in this recall (BCI 2 Panel Pouch Lot # 11YA20/ Kit Lot # 2039020). 2. Discontinue use and discard any remaining product in your possession that is subject to this recall. BioFire will replace the product at no charge in accordance with Biofire's Standard limited Warranty 3.Confirm the amount of pouches scr |
| Quantity | 870 kits |
| Distribution | US nationwide distribution |
| 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 |