Magellan LeadCare¿ II Blood Lead Test Kit — Class II medical device recall Z-0285-2019
Terminated recall by Magellan Diagnostics, Inc., reported 2018-11-07, distributed nationwide. Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generat
| Recall number | Z-0285-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Magellan Diagnostics, Inc., North Billerica, MA, United States |
| Recall initiated | 2018-08-08 |
| Classified | 2018-10-26 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2020-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | ES, ZA |
| Quantity | 1,465 kits |
| UPC / GTIN / UDI-DI | 00850355006000 |
| Lot numbers | 1808M, 1808M-01, 1808M-02, 1808M-03, 1808M-04, 1808M-05, 1808M-06, 1808M-07, 1808M-08, 1808M-09 |
| Model numbers | 70-6762 |
| Expiration dates | 2019-11-10 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0285-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.