FDA Device recall Z-1895-2026
LeadCare Ultra 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 Ultra 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-1895-2026 |
| 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 Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 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: 70-8098; UDI-DI: 00850355006024; 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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1895-2026%22
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