BEUDAMED
    FDA Recall Terminated

    Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare 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 this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.

    Recall: Z-2226-2017 · Initiated May 23, 2017

    Recall

    Recall Number
    Z-2226-2017
    Event Number
    77211
    Firm
    Magellan Diagnostics, Inc.
    FEI Number
    1218996
    Product Code
    DOF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 23, 2017
    Posted
    June 5, 2017
    Terminated
    July 8, 2021
    Address
    101 Billerica Ave, Bldg 4, North Billerica, MA, 01862-1271

    Description

    Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare 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 this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.

    Reason

    Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems

    Action

    Magellan issued a Safety Notification letter from May 23-25, 2017 . The firm states following the FDA Safety Notice, published May 17, 2017, this notification is to advise your facility regarding a change to existing LeadCare product usage and labeling. Prior instructions for use included capillary and venous blood samples. However, because the LeadCare Testing Systems may underestimate blood lead levels and give inaccurate results when processing venous blood samples, the FDA recommends discontinuing the use of venous blood samples with any LeadCare Blood Lead Testing System (LeadCare, LeadCare II, LeadCare Ultra, LeadCare Plus). Capillary samples may still be used on all LeadCare prducts listed above. Users requested to complete/sign Fax Form Record to verify that you have read and understood the Safety Communication to Customers on page 1. Contact Reba Daoust, Director of QA/RA 978-248-4811 or [email protected]

    Distribution

    Worldwide Distribution - US (Nationwide) Foreign: AUSTRALIA AUSTRIA BOLIVIA CANADA CHILE CHINA COLOMBIA DOMINICAN REPUB ENGLAND GERMANY INDIA UK ISRAEL ITALY JAPAN KOREA MALI MYANMAR SPAIN NEPAL NETHERLANDS NEW ZEALAND P.R. CHINA PANAMA US PERU PHILLIPINES POLAND PORTUGAL REP OF KOSOVO SOUTH AFRICA SRI LANKA USA SWEDEN SWITZERLAND TRINIDAD UNITED ARAB EMI VIETNAM

    Quantity

    6018 kits (total)= 5818 (US)and 200 (OUS)