FDA Device recall Z-1894-2026
LeadCare¿ Plus Blood Lead Test Kit
- FDA Device
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of LeadCare¿ Plus Blood Lead Test Kit by Magellan Diagnostics, citing customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1894-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-13 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Magellan Diagnostics |
| Distribution | US |
Product
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
Reason
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Identifiers
| code_info | Catalog Number: 82-0004; UDI-DI: 00850355006031; ALL lots and ALL sublots; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Magellan Diagnostics
- LeadCare II Blood Lead Test Kit
FDA Device · Class III · 2026-10-21 · Magellan Diagnostics - LeadCare Ultra Blood Lead Test Kit
FDA Device · Class II · 2026-04-29 · Magellan Diagnostics - (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit
FDA Device · Class II · 2026-04-29 · Magellan Diagnostics - The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood
FDA Device · Class II · 2025-12-03 · Magellan Diagnostics - LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only
FDA Device · Class II · 2023-11-15 · Magellan Diagnostics
All Magellan Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1894-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.