FDAFDA · Alimentos y medicamentos·N.º oficial Z-2456-2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853
Publicado el 7 de agosto de 2024 · Inicio del retiro: 19 de junio de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- BioFire Diagnostics, LLC
- Distribuidor
- Worldwide - US Nationwide distribution including in the states of FL, IL, KY, CO, KS, NC, AK, NY, ND, CA, TX, MD, GA, OH, WI, SD, LA, MT, VA, IA, MO, MA, WV, NE, OK, AZ, OR, SC, MI, IN, ID, TN, WA, NM, NJ, AR, AL, MN, NH, NV, PA, WY, MS, CT and the countries of AE, AM, AR, AT, BA, BG, BH, BN, BR, CA, CH, CI, CK, CN, CO, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GA, GB, GE, GR, GT, HR, HU, IL, IN, IQ, IS, IT, JO, JP, KK, KR, KW, LB, LT, LV, MK, MM, MX, MY, NG, NO, NW, OM, PA, PH, PK, PL, PT, QA, RO, RS, SA, SI, TN, TR, TW, UG, UY, VN, WF.
- Lote
- BCID2 Panel REF: RFIT-ASY-0147, UDI-DI: 00815381020338, All unexpired lots. BACT/ALERT REF/UDI-DI: Lot/Expiration: 410851/03573026596057: 0004101638/3/20/2024, 0004101930/7/28/2024, 0004102026/9/4/2024, 0004102408/2/16/2025, 0004102996/9/24/2025, 0004102946/8/29/2025, 0004102956/9/17/2025, 0004102998/9/24/2025. 410853/03573026596095: 0004101718/4/24/2024, 0004101790/6/1/2024, 0004101958/8/3/2024, 0004102452/3/3/2025, 0004102964/9/19/2025
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.