Class II — Magellan Diagnostics, Inc.
| Recalling firm | MAGELLAN Diagnostics INC. |
|---|---|
| Registered facility | Magellan Diagnostics, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 #2333 can lead to delayed or erroneous high or erroneous low results. |
| Product | The LeadCare® II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare® II Test Kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50) " Transfer Droppers (50) " Calibration Button (1) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL) |
| Quantity | 1,774 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2024-02-23 |
| Classified | 2025-11-21 |
| Recall number | Z-0584-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Magellan Diagnostics, Inc. (Z-0584-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97858/
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