BEUDAMED
    FDA Recall Terminated

    Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B2-microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.

    Recall: Z-1030-2016 · Initiated November 3, 2015

    Recall

    Recall Number
    Z-1030-2016
    Event Number
    73080
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JZG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 3, 2015
    Posted
    March 1, 2016
    Terminated
    January 13, 2017
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B2-microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.

    Reason

    Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista B2MIC Flex reagent cartridge: Dimension Vista System Flex reagent cartridge and urine stabilizer B2MIC. In the unlikely event that a patient result is generated, a suppressed result would be in conflict with the patients clinical status and other markers of renal injury.

    Action

    Siemens sent an Urgent Medical Device Recall dated November 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use and discard your remaining inventory of the affected product. Indicate your replacement product needs on the attached Field Correction Effectiveness Check Form and return. For questions call Siemens Customer Care Center- Technical Solutions at 800-441-9250 or your local Siemens technical support representative.

    Distribution

    Worldwide Distribution and US in the state of CA.

    Quantity

    1637 units.