# FDA recall Z-3035-2017

> **Magellan Diagnostics, Inc.** · Class II · device recall initiated 2016-01-20.

## Product

LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls    Product Usage:  IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.

## Reason for recall

LeadCare II Test Kits controls out of range

## Distribution

Worldwide - US Nationwide distribution and the countries of:  COLOMBIA, CANADA, THAILAND, INDIA, UAE, AUSTRALIA, GERMANY, CANADA, SOUTH AFRICA, SPAIN, NEW ZEALAND, KOREA

## Key facts

- **Recall number:** Z-3035-2017
- **Recalling firm:** Magellan Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-01-20
- **Report date:** 2017-08-23
- **Termination date:** 2018-02-21

- **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-3035-2017

## Citation

> AI Analytics. FDA recall Z-3035-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-3035-2017. Source: US FDA. Licensed CC0.

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