Magellan LeadCare Plus Blood Lead Analyzer Recalled for Battery Overheating Risk
Magellan Diagnostics is recalling 79 LeadCare Plus Blood Lead Analyzers because incorrect battery placement may cause overheating and potential finger burns.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product (potential burn injury) where no specific injuries have been reported yet, fitting the criteria for a High severity score.
Plain-English summary
Magellan Diagnostics, Inc. is recalling 79 units of the LeadCare Plus Blood Lead Analyzer (Part Number: 82-0001). The recall applies to all LeadCare II and LeadCare Plus Blood Lead Analyzers equipped with battery boards versions B and O. These devices are intended for the quantitative measurement of lead in a whole blood sample and were distributed worldwide.
The recall was initiated because the incorrect placement of AA batteries into the analyzer may cause the batteries to overheat. If the batteries are removed while hot, there is a chance that a user could burn their fingers.
Consumers who possess these devices should stop using them and contact Magellan Diagnostics for further instructions on how to proceed with the recall.
The recalled product
- Product
- LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
- Manufacturer
- Magellan Diagnostics, Inc.
- Hazard
- Affected units
- 79
Distribution
Distribution scope not specified by the agency.
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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