Magellan Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0285-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II 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 the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.

Product Classification:

Class II

Date Initiated: August 8, 2018

Date Posted: November 7, 2018

Recall Number: Z-0285-2019

Event ID: 81074

Reason for Recall:

Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH.

Status: Terminated

Product Quantity: 1,465 kits

Code Information:

Lot 1808M and sub-lots: 1808M-01, 1808M-02, 1808M-03, 1808M-04, 1808M-05, 1808M-06, 1808M-07, 1808M-08, 1808M-09. Exp. Date:November 10, 2019

Distribution Pattern:

Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated