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)
Enforcement
- Recall Number
- Z-1894-2026
- Event ID
- 98502
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Magellan Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 29, 2026
- Initiation Date
- March 13, 2026
- Classification Date
- April 17, 2026
- Address
- 101 Billerica Ave Bldg 4, N/A, North Billerica, MA, 01862-1271, United States
Description
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)
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.
Catalog Number: 82-0004; UDI-DI: 00850355006031; ALL lots and ALL sublots;
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.
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