BEUDAMED
    FDA Enforcement Class II Terminated

    EliA Sample Diluent, Article number, 83-1023-01

    Recall: Z-1253-2017 · Reported March 8, 2017

    Enforcement

    Recall Number
    Z-1253-2017
    Event ID
    76343
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Phadia US Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 8, 2017
    Initiation Date
    January 30, 2017
    Classification Date
    February 24, 2017
    Termination Date
    August 7, 2017
    Address
    4169 Commercial Ave, N/A, Portage, MI, 49002-9701, United States

    Description

    EliA Sample Diluent, Article number, 83-1023-01

    Reason

    Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems with the liquid level detection in diluent bottle batch JJCA resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate.

    Code Info

    EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C

    Distribution

    Domestic: AR, CA, CO, FL, GA, IL, IN, KY, LA, MI, MN, MO, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, WI, WV Foreign: None VA/DOD: None

    Quantity

    5957