# FDA recall Z-0219-2024

> **Magellan Diagnostics, Inc.** · Class II · device recall initiated 2023-09-19.

## Product

LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.

## Reason for recall

During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-to-tube seals. Manufacturing with these caps may result in cap-to-tube seals that allow leaking of HCl or may result in cap-to-tube seals that allow evaporation of treatment reagent. The consequence of this would be a change in the volume of treatment reagent and a change in the ratios of either added patient sample or control material to treatment reagent. The result of this might be a falsely elevated result (e.g., a patient false positive [PATFP] result or a Controls Out of Range-High [COOR-Hi] result).

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0219-2024
- **Recalling firm:** Magellan Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-19
- **Report date:** 2023-11-15

- **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-0219-2024

## Citation

> AI Analytics. FDA recall Z-0219-2024. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-0219-2024. Source: US FDA. Licensed CC0.

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