The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The
FDA device recall Z-0584-2026 · posted 2025-11-21 · Open, Classified
Recall details
- Recalling firm
- Magellan Diagnostics, Inc.
- 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.
- 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.
- Root cause
- Labeling mix-ups
- Status
- Open, Classified
- Product code
- DOF
- Quantity affected
- 1,774 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-02-23
- Date posted
- 2025-11-21
- Location
- North Billerica, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEADCARE II BLOOD LEAD TESTING SYSTEM (K052549) | Esa Biosciences, Inc. | 2005-10-06 |