BEUDAMED
    FDA Enforcement Class II Terminated

    ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.

    Recall: Z-0379-2017 · Reported November 16, 2016

    Enforcement

    Recall Number
    Z-0379-2017
    Event ID
    75448
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 16, 2016
    Initiation Date
    October 11, 2016
    Classification Date
    November 9, 2016
    Termination Date
    May 17, 2017
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502, United States

    Description

    ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.

    Reason

    Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).

    Code Info

    Lot: 31497UN14 Exp.: 17 Oct. 2016; Lot: 09353UNI15 Exp.: 12 Feb. 2017; Lot: 45216UN15 12 May 2017; Lot: 14596UN15 Exp.: 30 Jul. 2017; Lot: 37055UN15 Exp.: 12 Oct. 2017; Lot: 14782UN16 Exp.: 21 Apr. 2018

    Distribution

    Nationwide and Worldwide Distribution.

    Quantity

    26, 837 kits