LeadCare Ultra Blood Lead Test Kit Recalled for False Positive Results
Magellan Diagnostics is recalling the LeadCare Ultra Blood Lead Test Kit (Catalog Number 70-8098) because use with certain third-party micro-collection devices may produce unexpectedly elevated and false positive results, potentially causing delayed diagnosis and unnecessary additional testing.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a diagnostic device with a labeling/performance issue—false positive results—rather than a direct safety hazard. No hospitalizations, injuries, or deaths have been reported. The hazard is operational/diagnostic accuracy rather than physical harm, making this a moderate-severity precautionary recall.
Plain-English summary
Magellan Diagnostics, Inc. is recalling the LeadCare Ultra Blood Lead Test Kit, Catalog Number 70-8098, worldwide. The kit includes sensors, treatment reagent tubes, calibration button, and lead control materials used for blood lead testing.
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. These false positive lead results may cause delayed results and additional unnecessary testing.
All lots and sublots of the product are affected. Healthcare providers and laboratories using this kit with third-party micro-collection devices should stop use and contact Magellan Diagnostics for further guidance. Patients who may have received false positive results should be notified and may require retesting using alternative collection methods or devices.
The recalled product
- Product
- LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead…
- Manufacturer
- Magellan Diagnostics, Inc.
- Affected units
- 284
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 (3)
- Catalog Number: 70-8098
- UDI-DI: 00850355006024
- ALL lots and ALL sublots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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