BEUDAMED
    FDA Recall Terminated

    Advanced Instrument Model 2020 Multi-Sample Osmometer Intended to measure the osmotic pressure of body fluids.

    Recall: Z-2068-2011 · Initiated January 19, 2011

    Recall

    Recall Number
    Z-2068-2011
    Event Number
    58042
    Firm
    Advanced Instruments, Inc. Two Technology Way
    FEI Number
    1217058
    Product Code
    GKE
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 19, 2011
    Posted
    April 26, 2011
    Terminated
    December 1, 2011
    Address
    Norwood, MA, 02062-2633

    Description

    Advanced Instrument Model 2020 Multi-Sample Osmometer Intended to measure the osmotic pressure of body fluids.

    Reason

    A poorly soldered power cord may pose a potential electrical shock hazard.

    Action

    Advanced Instruments Product Service Department contacted each customer on 1/19/11 via an Urgent Product Recall Notice. The letter identified the reason for recall along with the affected products. The letter provided instructions to safely examine the date code of the AC Power Inlet assembly on the affected product. If customers were unable to perform the inspection or had questions concerning the instructions, they were to contact Advanced Instruments Product Service Manager at 781-471-2147 or via email [email protected]. The attached response forms were to be completed and returned as instructed.

    Distribution

    Worldwide Distribution -- USA, including states of CA, GA IL, NJ, and MA and country of Belgium.

    Quantity

    3 units