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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1296-2018%22
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