# FDA recall Z-1295-2018

> **Magellan Diagnostics, Inc.** · Class II · device recall initiated 2018-01-09.

## 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.

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-1295-2018
- **Recalling firm:** Magellan Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-09
- **Report date:** 2018-04-11
- **Termination date:** 2020-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Billerica, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1295-2018

## Citation

> AI Analytics. FDA recall Z-1295-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1295-2018. Source: US FDA. Licensed CC0.

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