FDA Device recall Z-1295-2018
LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only
- FDA Device
- Class II
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class II recall of LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only by Magellan Diagnostics, citing the incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1295-2018 |
| 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 II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.
Reason
The incorrect placement of AA batteries into certain LeadCare II 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 Numbers: 70-6760, 70-6529-R, 70-6760-P, and 70-6760-R. 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-1295-2018%22
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