The LeadCare¿ II Blood Lead Test System relies on electrochemistry… — Class II medical device recall Z-0584-2026
Ongoing recall by Magellan Diagnostics, Inc., reported 2025-12-03, distributed nationwide. Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The
| Recall number | Z-0584-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Magellan Diagnostics, Inc., North Billerica, MA, United States |
| Recall initiated | 2024-02-23 |
| Classified | 2025-11-21 |
| Reported by FDA | 2025-12-03 |
| Distributed | Nationwide (US) |
| Quantity | 1,774 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00850355006000 |
| Model numbers | 70-6762 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0584-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.