Magellan Diagnostics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0584-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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)

Product Classification:

Class II

Date Initiated: February 23, 2024

Date Posted: December 3, 2025

Recall Number: Z-0584-2026

Event ID: 97858

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.

Status: Ongoing

Product Quantity: 1,774 units

Code Information:

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;

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated