BEUDAMED
    FDA Recall Terminated

    Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.

    Recall: Z-1256-2019 · Initiated January 11, 2019

    Recall

    Recall Number
    Z-1256-2019
    Event Number
    82011
    Firm
    Lin-Zhi International Inc
    FEI Number
    3003610499
    Product Code
    DIC
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    January 11, 2019
    Terminated
    March 22, 2021
    Address
    2945 Oakmead Village Ct, Santa Clara, CA, 95051-0812

    Description

    Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.

    Reason

    Shelf life of the product may be reduced due to degradation of the assay.

    Action

    Lin-Zhi International initiated the recall by email to its distributors on 01/11/2019. The letter identified the affected product, problem and actions to be taken. The distributors were directed to notify their customers and requested the destruction of the recalled product. For questions call T: ( 408) 970-8811 E: [email protected]

    Distribution

    US Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR

    Quantity

    49 kits