BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-0451-2024 · Initiated October 17, 2023

    Recall

    Recall Number
    Z-0451-2024
    Event Number
    93360
    Firm
    BioFire Diagnostics, LLC
    FEI Number
    3002773840
    Product Code
    PEN
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    October 17, 2023
    Posted
    December 1, 2023
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248

    Description

    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

    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.

    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 alternate Quality Control materials such as those in FLM1-PRT-0251. 3) Complete and return the via email to [email protected] Contact customer support at [email protected] or via telephone by dialing 1.800.735.6544 and selecting option 5 for Product Technical Support with any questions or concerns.

    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, Armenia, Bahrain, Bolivia, Bosnia- Herzegovina, Brunei, Bulgaria, Costa Rica, Croatia, Cyprus, Dominican Republic, Dutch Antilles, Ecuador, El Salvador, Estonia, Gabon, Georgia, Guam, Guatemala, Honduras, Indonesia, Ireland, Iceland, Israel, Ivory Coast, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Macao, Macedonia, Malaysia, Mali, Mongolia, Morocco, New Zealand, Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Qatar, Romania, Saudi Arabia, Serbia , Slovenia, Tunisia, Uganda, United Arab Emirate, Uruguay, Venezuela, Vietnam, Zimbabwe, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Spain, France, United Kingdom, Greece, India, Italia, Japan, Korea, Netherlands, Poland, Portugal, Sweden, Singapore, Thailand, Turkey, Taiwan, Switzerland, Austria, Denmark, Finland, Germany, Belgium, Hungary, South Africa, Philippines, Norway, Mexico

    Quantity

    32,910