FDA Device recall Z-1893-2026
(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
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X 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-1893-2026 |
| 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
(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II 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
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(s): (1) 70-6762, (2) 70-6762RUO; UDI-DI: 00850355006000; ALL lots and ALL sublots; Catalog Number(s): (…Catalog Number(s): (1) 70-6762, (2) 70-6762RUO; UDI-DI: 00850355006000; ALL lots and ALL sublots; Catalog Number(s): (3) 70-8404; UDI-DI: 00850355006086; ALL lots and ALL sublots; Catalog Number(s): (4) 70-9000; UDI-DI: 00850355006093; 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-1893-2026%22
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