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 | Terminated |
| Reason | 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. |
| Product | 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. |
| Quantity | 1,465 kits |
| Distribution | Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa. |
| Initiated | 2018-08-08 |
| Classified | 2018-10-26 |
| Terminated | 2020-05-12 |
| Recall number | Z-0285-2019 |
| 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-0285-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81074/
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