BEUDAMED
    FDA Recall Terminated

    Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and treatment reagent of the test kit are specific for lead only. Contents of the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.

    Recall: Z-0285-2019 · Initiated August 8, 2018

    Recall

    Recall Number
    Z-0285-2019
    Event Number
    81074
    Firm
    Magellan Diagnostics, Inc.
    FEI Number
    1218996
    Product Code
    DOF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 8, 2018
    Terminated
    May 12, 2020
    Address
    101 Billerica Ave, Bldg 4, North Billerica, MA, 01862-1271

    Description

    Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and treatment reagent of the test kit are specific for lead only. Contents of the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.

    Reason

    Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 g/dL). Results for patient testing with this lot will be displayed as HIGH.

    Action

    The firm, Magellan, notified the Customers (end users) by telephone or email on August 8, 2018 to provide notification of the deficiency of the LeadCare II Blood Lead Test Kit having Lot Number 1808M. Replacement Buttons and an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 9 2018 ( were shipped on August 9, 2018, for delivery on Friday, August 10, 2018.) The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Do NOT use the Yellow calibration button marked 1808M. 2. Discard the Yellow calibration button that came with the LeadCare II Test Kit Lot 1808M. 3. Place the new Blue calibration button with the test kit and use for controls and patient testing with Lot 1808M. 4. Inform your staff of the calibration button exchange. 5. Complete the fax form record included with this letter and fax to 978-600-1480 or email a scanned copy of the completed form to [email protected]. If you have questions, please contact us at 800-275-0102 or [email protected].

    Distribution

    Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa.

    Quantity

    1,465 kits