# FDA recall Z-1952-2021

> **Magellan Diagnostics, Inc.** · Class I · device recall initiated 2021-05-07.

## Product

LeadCare II Blood Lead Test Kit  Catalog Number  	70-6762

## Reason for recall

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.

## Distribution

Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.

## Key facts

- **Recall number:** Z-1952-2021
- **Recalling firm:** Magellan Diagnostics, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-07
- **Report date:** 2021-07-07
- **Termination date:** 2023-10-24

- **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-1952-2021

## Citation

> AI Analytics. FDA recall Z-1952-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1952-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*