FDA Device recall Z-1925-2017
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
- FDA Device
- Class I
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class I recall of Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010 by Magellan Diagnostics, citing leadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1925-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-11-29 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Magellan Diagnostics |
| Distribution | US |
Product
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Reason
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1925-2017%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.