Z-2456-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2024
- Initiation Date
- June 19, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 99,822
Product Description
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
Reason for Recall
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.
Distribution Pattern
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.
Code Information
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