BEUDAMED
    FDA Recall Terminated

    NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006

    Recall: Z-1692-2018 · Initiated November 2, 2017

    Recall

    Recall Number
    Z-1692-2018
    Event Number
    79303
    Firm
    PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6
    FEI Number
    3002808498
    Product Code
    NQL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 2, 2017
    Terminated
    September 17, 2019
    Address
    P.O. Box 10, Turku Finland

    Description

    NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006

    Reason

    There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacetone reagent vials.

    Action

    Actions to be taken: - Inspect your inventory of the NeoBase Succinylacetone Assay Solution vials for the affected lots. - If you notice leakage or deformed stopper seals, destroy the affected vials according to local instructions and regulations. - Complete the Response Form with the quantity and identity of affected Succinylacetone Assay Solution vials in your inventory. - Return the Response Form to PerkinElmer. - PerkinElmer will replace the quantity of leaking Succinylacetone Assay Solution vials found and destroyed from your inventory

    Distribution

    Distributed in 20 US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MO, NV, OH, OR, SC, TN, TX.

    Quantity

    5275