FDA Device recall Z-2226-2017
Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits
- FDA Device
- Class I
- terminated
- Published 2017-06-14
On 2017-06-14 the FDA classified a Class I recall of Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits by Magellan Diagnostics, citing underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2226-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-05-23 |
| Published | 2017-06-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Magellan Diagnostics |
| Distribution | US |
Product
Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
Reason
Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
Identifiers
| code_info | All lot codes |
|---|
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-2226-2017%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.