Magellan Diagnostics, Inc.: LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004;

Magellan Diagnostics, Inc.: LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors

Medical DevicesSource: FDA (device) · Date: 2026-04-29

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: Magellan Diagnostics, Inc.
Product: LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
Reason / hazard: 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
Status: Ongoing
Distribution / sold at: 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.
Recall initiated: 2026-03-13
Code info: Catalog Number: 82-0004; UDI-DI: 00850355006031; ALL lots and ALL sublots;
Product quantity: 136
Voluntary mandated: Voluntary: Firm initiated
City: North Billerica
State: MA
Country: United States
Event id: 98502