Magellan Diagnostics, Inc.: Medical Device Recall in 2017 - (Recall #: Z-3035-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 20, 2016

Date Posted: August 23, 2017

Recall Number: Z-3035-2017

Event ID: 77695

Reason for Recall:

LeadCare II Test Kits controls out of range

Status: Terminated

Product Quantity: 12,931 kits

Code Information:

Lot # :1507N Exp Date: 1/27/17; Lot # :1508N Exp Date: 2/27/17; Lot # :1510N Exp Date: 4/19/17; Lot # :1511M Exp Date: 5/3/17 Lot # :1511N Exp Date: 5/17/17 Lot # :1512M Exp Date: 6/2/17

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated