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 | LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system. |
| Product | Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 |
| Quantity | 1016 |
| Distribution | Nationwide Distribution |
| Initiated | 2014-11-29 |
| Classified | 2017-05-17 |
| Terminated | 2022-02-26 |
| Recall number | Z-1926-2017 |
| 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-1926-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76991/
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