BEUDAMED
    FDA Enforcement Class II Terminated

    PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.

    Recall: Z-3186-2018 · Reported September 26, 2018

    Enforcement

    Recall Number
    Z-3186-2018
    Event ID
    80724
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 26, 2018
    Initiation Date
    April 30, 2018
    Classification Date
    September 17, 2018
    Termination Date
    April 17, 2019
    Address
    510 Furnace Dock Rd, N/A, Cortlandt Manor, NY, 10567-6220, United States

    Description

    PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.

    Reason

    A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. If the cartridge with leakage is used, higher measurement value as low as +12% and no higher than +20% bias may be obtained.

    Code Info

    Lot : A735 Exp: 10/31/2018 UDI: (01)04987595301636(17)181031(10)A735 and Lot: O736 Exp: 01/03/2019 UDI: (01)04987595301636(17)190131(10)O736

    Distribution

    US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.

    Quantity

    272 KITS in total