FDA Device recall Z-1296-2018
LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample
- FDA Device
- Class II
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class II recall of LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample by Magellan Diagnostics, citing the incorrect placement of AA batteries into certain LeadCare Plus Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1296-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-09 |
| Published | 2018-04-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Magellan Diagnostics |
| Distribution | n/a |
Product
LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
Reason
The incorrect placement of AA batteries into certain LeadCare Plus Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.
Identifiers
| code_info | Part Number: 82-0001. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Magellan Diagnostics
- LeadCare II Blood Lead Test Kit
FDA Device · Class III · 2026-10-21 · Magellan Diagnostics - LeadCare¿ Plus Blood Lead Test Kit
FDA Device · Class II · 2026-04-29 · 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
All Magellan Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1296-2018%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.