# FDA recall Z-0584-2026

> **Magellan Diagnostics, Inc.** · Class II · device recall initiated 2024-02-23.

## Product

The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood.    The LeadCare¿ II Test Kit is provided with the following materials:  " Sensors (2 Containers of 24 sensors each; 48 tests)  " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests)  " Heparinized Capillary Tubes/Plungers (50)  " Transfer Droppers (50)  " Calibration Button (1)  " Lead Control Level 1 (1 @ 2 mL)  " Lead Control Level 2 (1 @ 2 mL)

## Reason for recall

Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0584-2026
- **Recalling firm:** Magellan Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-23
- **Report date:** 2025-12-03

- **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-0584-2026

## Citation

> AI Analytics. FDA recall Z-0584-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0584-2026. Source: US FDA. Licensed CC0.

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