Recall Z-0451-2024 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
BioFire Diagnostics, LLC
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251
| Date | Dec 1, 2023 (initiated Oct 17, 2023) |
| Status | Open, Classified |
| Reason | Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some portion of test runs, but then it's reported as "Not Detected" because the assay amplicon Tm is outside the acceptable limit assigned for calling positive results. |
| Root cause | Process control |
| Action | On 10/17/23, "URGENT: MEDICAL DEVICE CORRECTION" notices were mailed to customers who were asked to do the following: 1) Review a complete list of BIOFIRE Quality Control Materials and references, for Example IQCP Risk Analysis can be found in BIOFIRE QC Tech Note (FLM1-PRT-0251), available from bioMrieux customer support. 2) Assess your Individualized Quality Control Plan (IQCP) and prepare for supplemental C. tropicalis testing if a Candida tropicalis Not Detected result is reported when testing with the MMQCI FilmArray BCID2 Control Panel M416 and/or amend testing plans to include alterna |
| Quantity | 32,910 |
| Distribution | Worldwide Distribution: US (nationwide): DE, OH, NY, IL, KY, FL, GA, KS, CA, WI, NC,, AK, PA, MN, ND, IN, AR, CO, UT, TX, AL, NJ, MD, SD, LA, OR, MA, ID, NE, MT, VA, IA, MO, WV, TN, MI, WY, SC, AZ, WA, NH, OK, HI, MS, DC, VT, CT, NM, RI, ME, NV; and OUS (foreign) to countries of: Algeria, Angola, |
| 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 |