BEUDAMED
    FDA Recall Terminated

    MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2

    Recall: Z-2867-2017 · Initiated May 22, 2017

    Recall

    Recall Number
    Z-2867-2017
    Event Number
    77405
    Firm
    Sentinel CH SPA Via Robert Koch
    FEI Number
    3000303338
    Product Code
    JFY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 22, 2017
    Posted
    June 27, 2017
    Terminated
    September 4, 2018
    Address
    2 Milan Italy

    Description

    MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2

    Reason

    Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.

    Action

    Sentinel Diagnostics notified the US Distributor on 5/22/17 to notify US customers by letter. Actions to be Taken 1. Discontinue the use of the impacted lots immediately and destroy any remaining inventory of impacted lots according to your laboratory procedures. 2. If you have an alternate reagent lot available in inventory, switch to this alternate lot, or use a new lot provided. 3. Please review the content of this communication with your Medical Director and retain this letter for any future reference. Questions regarding this information, U.S. Customers should contact Customer Service at 1-877-4 ABBOTT. Customers to complete Field Safety Notice Receipt.

    Distribution

    Nationwide Distribution

    Quantity

    2356 kits Worldwide; US 206 kits