Magellan Diagnostics, Inc. recalls Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is

Recalled June 14, 2017 · FDA recall Z-2226-2017 · Magellan Diagnostics

Hazard

Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems · FDA Class I

Units

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

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Magellan Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →