BEUDAMED
    FDA Recall Terminated

    -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

    Recall: Z-0446-2019 · Initiated September 10, 2018

    Recall

    Recall Number
    Z-0446-2019
    Event Number
    81197
    Firm
    BioFire Diagnostics, LLC
    FEI Number
    3002773840
    Product Code
    PLO
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    September 10, 2018
    Terminated
    April 28, 2021
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248

    Description

    -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

    Reason

    Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.

    Action

    On 09/10/2018, the firm sent an Urgent Medical Device Recall Letter via FedEx to the Recall Coordinator/Laboratory Director for all consignees. Consignees are instructed to: -Immediately examine their inventory for products with the affected Lot numbers and to discontinue use and to discard any remaining product in their possession that is subject to the recall.. BioFire will replace discarded product at no charge. -If the consignee has further distributed the affected product, they are to identify these customers and to notify them at once of the product recall. -Complete and return the Acknowledgement of Receipt Form that was enclosed with the Customer Advisory Notice letter, as soon as possible, and to return the Acknowledgement Form to the firm. Consignees were provided with firm contact information including phone numbers: 801-736-6354 and 1-800-735-6544

    Distribution

    Worldwide Distribution - US Nationwide in the states of: CA DC, FL, IN, KY, MN, MO, NB, NJ, OH, TX and WI. International: Canada, Columbia and Mexico

    Quantity

    1350 pouches