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)
This recall is currently active, issued November 21, 2025. It was issued by Magellan Diagnostics, Inc..
- Company
- Magellan Diagnostics, Inc.
- Recall Initiated
- February 23, 2024
- Posted
- November 21, 2025
- Recall Number
- Z-0584-2026
- Quantity
- 1,774 units
- Firm Location
- North Billerica, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
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;
Root Cause
Labeling mix-ups
Action Taken
On March 3, 2024, MEDICAL DEVICE FIELD CORRECTION letters were sent to customers. Immediate Actions: 1. Identify existing inventory of impacted product and suspend its distribution. 2. Identify customers that received the impacted product and notify them about this field action. 3. Return remaining impacted product to Magellan Diagnostics, Inc. for destruction. To initiate the return process, ensure that you note the quantity of product to be returned on your Confirmation of Notification Form. Actions to Be Taken by Magellan: 1. Magellan Diagnostics will continue to investigate the cause of the labeling error and initiate appropriate preventive actions. 2. Magellan will replace unexpired impacted product upon request. Product will be replaced based on availability, and on a first-come first-served basis.