BEUDAMED
    FDA Recall 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 · Initiated April 30, 2018

    Recall

    Recall Number
    Z-3186-2018
    Event Number
    80724
    Firm
    Polymedco, Inc., Polymedco Cancer Diagnostic Products, Llc
    FEI Number
    1000119795
    Product Code
    NBC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 30, 2018
    Terminated
    April 17, 2019
    Address
    510 Furnace Dock Rd, Cortlandt Manor, NY, 10567-6220

    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.

    Action

    The firm, Polymedco, initiated a recall by telephone and followed with email on 4/30/18 to inform users to inspect the reagent cartridges for evidence of leakage from the ALP well and to discard cartridges that had evidence of leakage. Polymedco will replace any affected reagent cartridges. If you have any questions, contact Polymedco Technical Support at the 1.800.431.2123 Ext 285.

    Distribution

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

    Quantity

    272 KITS in total