BEUDAMED
    FDA Recall Terminated

    Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only

    Recall: Z-1157-2021 · Initiated January 26, 2021

    Recall

    Recall Number
    Z-1157-2021
    Event Number
    87282
    Firm
    BioFire Diagnostics, LLC
    FEI Number
    3002773840
    Product Code
    PEN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 26, 2021
    Terminated
    May 2, 2022
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248

    Description

    Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only

    Reason

    The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.

    Action

    On or around January 25, 2021, the firm send an UGENT: MEDICAL DEVICE CORRECTION letter via email to all affected consignees. The firm's recall strategy includes notification of all customers who have ordered the BCID or BCID2 Panel, within the last 12 months, using the aforementioned Customer Letters. The effectiveness of this communication will be verified by monitoring confirmation of the Acknowledgment of Receipt from each affected customer.

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Angola, Anguilla , Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Brunei. Daruss., Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Rep, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Utd/Arab Emir/, Vietnam.

    Quantity

    21,922 kits