LeadCare II Blood Lead Analyzer Part Numbers: 70-6760 — Class II medical device recall Z-1295-2018
Terminated recall by Magellan Diagnostics, Inc., reported 2018-04-11. The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries t
| Recall number | Z-1295-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Magellan Diagnostics, Inc., North Billerica, MA, United States |
| Recall initiated | 2018-01-09 |
| Classified | 2018-04-03 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2020-12-11 |
| Quantity | 6,143 |
| Reason classes | device malfunction |
| Model numbers | 70-6529-R, 70-6760, 70-6760-P, 70-6760-R |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1295-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.