BEUDAMED
    FDA Enforcement Class II Terminated

    STA SYSTEM CONROL N + P (ref. 00678)

    Recall: Z-0738-2020 · Reported January 1, 2020

    Enforcement

    Recall Number
    Z-0738-2020
    Event ID
    84402
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diagnostica Stago, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2020
    Initiation Date
    November 18, 2019
    Classification Date
    December 23, 2019
    Termination Date
    January 12, 2023
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607, United States

    Description

    STA SYSTEM CONROL N + P (ref. 00678)

    Reason

    A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.

    Code Info

    REF: 00678 Lot Numbers: 253145, 253416, 253655, 254040, 254206, 254401, 254573, 254760 UDIs: (01)03607450006780(11)171130(17)191130(10)253145(241)00678 (01)03607450006780(11)180131(17)200131(10)253416(241)00678 (01)03607450006780(11)180331(17)200331(10)253655(241)00678 (01)03607450006780(11)180630(17)200630(10)254040(241)00678 (01)03607450006780(11)180731(17)200731(10)254206(241)00678 (01)03607450006780(11)180930(17)200930(10)254401(241)00678 (01)03607450006780(11)181031(17)201031(10)254573(241)00678 (01)03607450006780(11)181130(17)201130(10)254760(241)00678

    Distribution

    US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK

    Quantity

    5,437