Home / Recalls / Medical Devices
Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection
Recalled August 23, 2017 · FDA recall Z-3035-2017 · Magellan Diagnostics
Hazard
LeadCare II Test Kits controls out of range · FDA Class II
Units
12,931 kits
Sold at
Worldwide - US Nationwide distribution and the countries of: COLOMBIA, CANADA, THAILAND, INDIA, UAE, AUSTRALIA, GERMANY, CANADA, SOUTH AFRICA, SPAIN, NEW ZEALAND, KOREA
Description
LeadCare II Test Kits controls out of range
Product
LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.
Manufacturer(s)
Magellan Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →