BEUDAMED
    FDA Recall Terminated

    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.

    Recall: Z-1171-2016 · Initiated January 22, 2016

    Recall

    Recall Number
    Z-1171-2016
    Event Number
    73129
    Firm
    Sekisui Diagnostics P.E.I. Inc.
    FEI Number
    3002806809
    Product Code
    LDP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 22, 2016
    Terminated
    August 9, 2016
    Address
    70 Watts Ave, Charlottetown Canada

    Description

    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.

    Reason

    Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover

    Action

    Sekisui sent an Important Field Correction - Customer Notification letter dated January 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Discard all reagent in house with a current expiration date of 2016-09. 2. Update the expiration on all remaining kits on hand with the new expiration dates provided 3. When adding additional reagent to the analyzer, a new reagent wedge should be used. 4. If crystals are observed within reagent stored on-board, reagent should be discarded and replaced with fresh reagent. 5. Complete, sign and return the attached CONFIRMATION OF NOTIFICATION form by FAX to the number provided. This will indicate receipt of this Field Correction, act as confirm action of compliance with the actions,and allow for issuance of replacement material for expired product on hand (lots 47677, 47694, 47695). Questions contact Technical Services at 1-800-565-0265 or via email at [email protected]

    Distribution

    Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong.

    Quantity

    14,407 kits.