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Lead, Atomic Absorption
FDA product code DOF · Class 2 · Clinical Toxicology
19
Registered devices
575
Adverse events
20
Recalls
6
510(k) clearances
Devices with this code
LeadCare® II Replacement AC Adapter and Plug Set — MAGELLAN DIAGNOSTICS, INC.LeadCare® II Blood Lead Analyzer Kit, Refurbished — MAGELLAN DIAGNOSTICS, INC.LeadCare® Plus Blood Lead Test Kit — MAGELLAN DIAGNOSTICS, INC.LeadCare® II Blood Lead Test Kit — MAGELLAN DIAGNOSTICS, INC.LeadCare® Heparinized Capillary Tubes — MAGELLAN DIAGNOSTICS, INC.LeadCare® II Blood Lead 6 Tests Kit — MAGELLAN DIAGNOSTICS, INC.LeadCare® II Blood Lead Testing System 9X ClinicalTest Kit — MAGELLAN DIAGNOSTICS, INC.LeadCare® Plus Blood Lead Analyzer Kit — MAGELLAN DIAGNOSTICS, INC.LeadCare® Ultra Blood Lead Analyzer Kit — MAGELLAN DIAGNOSTICS, INC.LeadCare® II Blood Lead Testing System 9X Test Kit — MAGELLAN DIAGNOSTICS, INC.LeadCare® Plus Data ManagementSystem — MAGELLAN DIAGNOSTICS, INC.LeadCare® Ultra Blood Lead Testing System — MAGELLAN DIAGNOSTICS, INC.LeadCare® II 5X Test Kit — MAGELLAN DIAGNOSTICS, INC.LeadCare® Ultra Blood Lead Test Kit — MAGELLAN DIAGNOSTICS, INC.LeadCare® Blood Lead Control Kit — MAGELLAN DIAGNOSTICS, INC.LeadCare® Plus Blood Lead Analyzer Kit — MAGELLAN DIAGNOSTICS, INC.LeadCare® II Blood Lead Analyzer Kit — MAGELLAN DIAGNOSTICS, INC.LeadCare® Blood Lead Test Kit — MAGELLAN DIAGNOSTICS, INC.LeadCare® Blood Collection Plungers — MAGELLAN DIAGNOSTICS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-13 | Magellan Diagnostics, Inc. | Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with |
| 2026-03-13 | Magellan Diagnostics, Inc. | Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with |
| 2026-03-13 | Magellan Diagnostics, Inc. | Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with |
| 2024-02-23 | Magellan Diagnostics, Inc. | Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #23 |
| 2023-09-19 | Magellan Diagnostics, Inc. | During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2021-05-07 | Magellan Diagnostics, Inc. | Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimati |
| 2021-05-07 | Magellan Diagnostics, Inc. | Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimati |
| 2021-05-07 | Magellan Diagnostics, Inc. | Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimati |
| 2018-08-08 | Magellan Diagnostics, Inc. | 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 |
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