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

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.

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)

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.

• FDA enforcement recordOfficial FDA database entry for Z-0584-2026
• FDA 510(k) clearance · K052549The device's official FDA premarket clearance record
• FDA device classification · DOFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.3550The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Magellan Diagnostics, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.