BEUDAMED
    FDA Enforcement Class II Terminated

    Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.

    Recall: Z-1703-2015 · Reported June 10, 2015

    Enforcement

    Recall Number
    Z-1703-2015
    Event ID
    71273
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2015
    Initiation Date
    March 25, 2015
    Classification Date
    June 2, 2015
    Termination Date
    January 24, 2017
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.

    Reason

    Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been observed. Patient samples with recoveries close to the medical decision points could exhibit a deviation up to 4 seconds for the normal range and up to 33% for the pathological range.

    Code Info

    Catalog Number B4218-1, Material Number 10445709, lot numbers 557128, 557129, 557130, 557131, 557132, 557133, 557134, 557135, 557140, 557141 , expiration dates:10/31/2015, 11/21/2015, 2/16/2016

    Distribution

    Worldwide Distribution. US naionwide including Puerto Rico, Barbados and Mexico.

    Quantity

    27501