Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh who...
FDA Device Recall #Z-0285-2019 — Class II — August 8, 2018
Recall Summary
| Recall Number | Z-0285-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 8, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Magellan Diagnostics, Inc. |
| Location | North Billerica, MA |
| Product Type | Devices |
| Quantity | 1,465 kits |
Product Description
Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and treatment reagent of the test kit are specific for lead only. Contents of the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.
Reason for Recall
Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH.
Distribution Pattern
Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa.
Lot / Code Information
Lot 1808M and sub-lots: 1808M-01, 1808M-02, 1808M-03, 1808M-04, 1808M-05, 1808M-06, 1808M-07, 1808M-08, 1808M-09. Exp. Date:November 10, 2019
Other Recalls from Magellan Diagnostics, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| 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-1953-2021 | Class I | LeadCare Plus Blood Lead Test Kit Catalog Numb... | May 7, 2021 |
| Z-1952-2021 | Class I | LeadCare II Blood Lead Test Kit Catalog Number... | May 7, 2021 |
| 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.