Class I — Magellan Diagnostics, Inc.
| Recalling firm | MAGELLAN Diagnostics INC. |
|---|---|
| Registered facility | Magellan Diagnostics, Inc. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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 underestimation of blood lead levels in patient samples. |
| Product | LeadCare II Blood Lead Test Kit Catalog Number 70-6762 |
| Quantity | 387,281 kits (48 tests/kit=1,757,040 tests) |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines. |
| Initiated | 2021-05-07 |
| Classified | 2021-07-01 |
| Terminated | 2023-10-24 |
| Recall number | Z-1952-2021 |
| 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 I recall — Magellan Diagnostics, Inc. (Z-1952-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87992/
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