The Recall Desk
ModerateFDA (Devices)·Z-1895-2026·Announced 2026-04-29

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.

What this means for you

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 Co
Manufacturer
Magellan Diagnostics, Inc.
Category
Medical Device — Diagnostic Test Kit
Hazard
  • false-positive-results
  • diagnostic-error

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.

Related recalls

Same category