The Recall Desk

FDA (Devices) recall action 77211

Magellan Diagnostics, Inc. recalled 2 products on 2017-06-14

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-06-14
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • HighFDA (Devices)··2017-06-14

    Magellan LeadCare Blood Lead Test Kits Recalled for Underestimating Results

    Magellan Diagnostics is recalling LeadCare and LeadCare II test kits because they may underestimate lead concentrations in venous blood samples.

    Product
    Magellan Diagnostics LeadCare and LeadCare II 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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-06-14

    Magellan LeadCare Blood Test Kits Underestimate Lead Concentrations

    Magellan Diagnostics is recalling LeadCare Ultra and Plus test kits because they may underestimate lead levels in venous blood samples.

    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. Sens
    Category
    Distribution
    0 states