Magellan Diagnostics, Inc. recalls The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to

Recalling company

Magellan Diagnostics, Inc.

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

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Feb 23, 2024

Reported

Dec 3, 2025

Distribution

US Nationwide distribution.

Status

Ongoing

Quantity

1,774 units

Lot / codes

Product Name: LeadCare¿ II Blood Lead Test Kit; Catalog Number: 70-6762; Impacted Lot/Sublot Numbers: 2333M, 2333M-01, 2333M-02, 2333M-03, 2333M-04, 2333M-05, 2333M-06, 2333M-07, 2333M-08, 2333M-09, 2333M-10, 2333M-11; Device Identifier: (01)00850355006000;

Company location

North Billerica, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-0584-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0584-2026 in the FDA Enforcement Report. Also see FDA recall press releases.