Magellan LeadCare Blood Analyzer Recall for Falsely Low Lead Results
Magellan Diagnostics is recalling LeadCare Ultra Blood Analyzers because they may generate falsely low lead concentrations when used with specific Becton Dickinson collection tubes.
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 may produce inaccurate diagnostic results (falsely low lead levels), which poses a risk of harm to patients by potentially missing a diagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Magellan Diagnostics, Inc. is recalling 49 units of the LeadCare Ultra Blood Analyzer (Part Number: 80-0010). The recall covers all serial numbers and the product was distributed nationwide.
The recall is being issued because the LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. This issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
Healthcare facilities and users of these analyzers should stop using the affected units and contact Magellan Diagnostics for instructions on how to proceed.
The recalled product
- Product
- Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
- Manufacturer
- Magellan Diagnostics, Inc.
- Hazard
- Affected units
- 49
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 serial numbers
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.
See all 2 products in this recall →Related recalls
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