Recall Z-0312-2022 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
BioFire Diagnostics, LLC
BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 442022/BD BACTEC Plus Anaerobic medium in plastic vials 442020/BD BACTEC Peds Plus mediums in plasti
| Date | Oct 11, 2021 |
| Status | Terminated |
| Reason | Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials. |
| Root cause | Material/Component Contamination |
| Action | On or about 10/10/2021, the Recalling Firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter to U.S. customer via overnight FedEx to inform them that there is an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results when the blood culture identification panels are used with some types of blood culture vials. The increased risk are potential due to an increased level of nucleic acid from non-viable Acinetobacter calcoaceticus- baumannii complex targets in the blood culture vials. Affected Blood Culture Media vials are: 442023 - BD BACTEC Plus Ae |
| Quantity | Total 14,140 Kits [11,155 kits (U.S.) and 2,985 kits (O.U.S.)] |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. The Countries of Algeria, Argentin |
| 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 |