Magellan Diagnostics, Inc. recalls LeadCare Ultra Blood Lead Test Kit

Recalling company

Magellan Diagnostics, Inc.

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 Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)

Reason

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. False positive lead results may cause delayed results and additional unnecessary testing.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Mar 13, 2026

Reported

Apr 29, 2026

Distribution

Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan, Bolivia, Canada, Chile, Diego Garcia, Ecuador, Eritrea, Georgia, Ghana, Guam, Guatemala, Haiti, Hong Kong, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kyrgyzstan, Mexico, Nepal, Peru, Philippines, South Africa, South Korea, Spain, UAE, Uruguay, Vietnam.

Status

Ongoing

Quantity

284

Lot / codes

Catalog Number: 70-8098; UDI-DI: 00850355006024; ALL lots and ALL sublots;

Company location

North Billerica, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-1895-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1895-2026 in the FDA Enforcement Report. Also see FDA recall press releases.