# FDA recall Z-0285-2019

> **Magellan Diagnostics, Inc.** · Class II · device recall initiated 2018-08-08.

## 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.

## Distribution

Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa.

## Key facts

- **Recall number:** Z-0285-2019
- **Recalling firm:** Magellan Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-08
- **Report date:** 2018-11-07
- **Termination date:** 2020-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Billerica, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0285-2019

## Citation

> AI Analytics. FDA recall Z-0285-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0285-2019. Source: US FDA. Licensed CC0.

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