LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided...
FDA Device Recall #Z-1894-2026 — Class II — March 13, 2026
Recall Summary
| Recall Number | Z-1894-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 13, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Magellan Diagnostics, Inc. |
| Location | North Billerica, MA |
| Product Type | Devices |
| Quantity | 136 |
Product 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)
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.
Distribution Pattern
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.
Lot / Code Information
Catalog Number: 82-0004; UDI-DI: 00850355006031; ALL lots and ALL sublots;
Other Recalls from Magellan Diagnostics, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1895-2026 | Class II | LeadCare Ultra Blood Lead Test Kit; Catalog Nu... | Mar 13, 2026 |
| Z-1893-2026 | Class II | (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)Lea... | Mar 13, 2026 |
| Z-0584-2026 | Class II | The LeadCare¿ II Blood Lead Test System relies ... | Feb 23, 2024 |
| Z-0219-2024 | Class II | LeadCare II Blood Lead Test Kit-For in vitro di... | Sep 19, 2023 |
| Z-1954-2021 | Class I | LeadCare Ultra Blood Lead Test Kit Catalog Num... | May 7, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.