Recall Z-1139-2024 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
BioFire Diagnostics, LLC
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplex nucleic acid assay for identification of microorganisms and resis
| Date | Feb 15, 2024 (initiated Jan 26, 2024) |
| Status | Open, Classified |
| Reason | Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums |
| Root cause | Under Investigation by firm |
| Action | On 01/26/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via overnight FedEx to customers to inform them of the increased risk of false positive Candida tropicalis results when the BIOFIRE BCID2 Panel is used with BD BACTEC blood culture vials including, but not limited to, the bottle types: BD BACTEC" Lytic Anaerobic medium BD BACTEC" Peds Plus medium BD BACTEC" Plus Aerobic medium BD BACTEC" Plus Anaerobic medium BD BACTEC" Standard Aerobic medium BD BACTEC" Standard Anaerobic medium Customers are requested to take the following actions: - If the BIOFIRE BCID2 Panel is used to |
| Quantity | 32,910 panels/pouches |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The |
| 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 |