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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that provides inaccurate diagnostic results (underestimating lead levels), which poses a risk of harm to patients through misdiagnosis or delayed treatment, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Magellan Diagnostics, Inc. is recalling the LeadCare Ultra and LeadCare Plus test kits. These products are used for the quantitative measurement of lead in fresh whole blood for professional, in vitro diagnostic use only. The recall covers 6,018 kits distributed in the United States and internationally.
The recall is being issued because the test kits may underestimate the lead concentration of venous blood samples when analyzed with the LeadCare systems. This inaccuracy could lead to incorrect clinical assessments of a patient's lead exposure.
The affected products were distributed nationwide in the US and in numerous foreign countries, including Australia, Canada, China, and the United Kingdom. All lot codes are included in this recall. Healthcare professionals and laboratories using these kits should stop using them and contact the manufacturer for instructions on how to proceed.
The recalled product
- 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
- Manufacturer
- Magellan Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Magellan Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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