Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of…

Recall date

January 20, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3035-2017

FDA classification

Class II

Brand / firm

Magellan Diagnostics, Inc.

Sold / distributed

Worldwide - US Nationwide distribution and the countries of: COLOMBIA, CANADA, THAILAND, INDIA, UAE, AUSTRALIA, GERMANY, CANADA, SOUTH AFRICA, SPAIN, NEW ZEALAND, KOREA

Why it was recalled

LeadCare II Test Kits controls out of range

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.