BEUDAMED
    FDA Recall Terminated

    LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.

    Recall: Z-1296-2018 · Initiated January 9, 2018

    Recall

    Recall Number
    Z-1296-2018
    Event Number
    79279
    Firm
    Magellan Diagnostics, Inc.
    FEI Number
    1218996
    Product Code
    DOF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 9, 2018
    Terminated
    December 11, 2020
    Address
    101 Billerica Ave, Bldg 4, North Billerica, MA, 01862-1271

    Description

    LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.

    Reason

    The incorrect placement of AA batteries into certain LeadCare Plus Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.

    Action

    An Urgent Medical Device Correction letter, dated January 9, 2018, was sent to customers. The letter identified the affected device and provided a description of the issue. If two of the four AA batteries are inserted incorrectly, the batteries may overheat, causing a minor burn if the user opens the battery compartment and tries to remove the hot batteries. Customers are to follow the steps outlined in the letter, including placing the enclosed label on the upper back panel of the analyzer to remind users who are changing batteries of the importance of correct placement. Proper battery placement should be provided in annual training. Customers are to complete and return the acknowledgement card. Please direct any questions to 800-275-0102 or [email protected].

    Distribution

    Worldwide Distribution

    Quantity

    79