LeadCare Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare Plus kit is provided with the following materia
FDA device recall Z-1894-2026 · posted 2026-04-17 · Open, Classified
Recall details
- Recalling firm
- Magellan Diagnostics, Inc.
- Reason for recall
- 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.
- Action taken
- On March 13, 2026, MEDICAL DEVICE FIELD CORRECTION letters were sent to customers. REQUIRED ACTIONS: This field action does NOT require removal of product from the field. The LeadCare Test Systems continue to perform as intended when used according to the product labeling and Instructions for Use. The regulatory status of all products noted above remains unchanged and the product supply uninterrupted. Technical and customer support will continue as normal. LEADCARE II: The only blood collection devices validated for use with the Magellan LeadCare II Blood Lead Test Kit are the capillary tubes provided in the LeadCare II Test Kit. No other collection device should be used for blood sample collection for testing with the LeadCare II System. LEADCARE PLUS AND ULTRA: End users must validate the use of micro-collection devices with LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems in accordance with their laboratory policies and procedures. REGARDING PREVIOUS RESULTS: Patients who have had elevated results when tested on the LeadCare Blood Lead Test Systems (LeadCare II, LeadCare Plus, and LeadCare Ultra) should have confirmatory testing performed in accordance with CDC or other applicable standards and guidelines.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- DOF
- Quantity affected
- 136
- 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
- Date initiated
- 2026-03-13
- Date posted
- 2026-04-17
- Location
- North Billerica, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LeadCare Plus Blood Lead Testing System (K142705) | Magellan Diagnostics | 2015-07-07 |