Device Recall LeadCare Blood Lead Testing System

  • Model / Serial
    All lot codes
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product Description
    Magellan Diagnostics LeadCare and LeadCare II 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Magellan Diagnostics, Inc., 101 Billerica Ave Bldg 4, North Billerica MA 01862-1271
  • Manufacturer Parent Company (2017)
  • Source
    USFDA