# FDA recall Z-1893-2026

> **Magellan Diagnostics, Inc.** · Class II · device recall initiated 2026-03-13.

## Product

(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ;  Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits);  The LeadCare II kit is provided with the following materials:   "	Sensors (2 Containers of 24 sensors each; 48 tests)   "	Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests)  "	Heparinized Capillary Tubes/Plungers (50 @)  "	Transfer Droppers (50 @)  "	Calibration Button (1 @)  "	Lead Control Level 1 (1 @ 2 mL)  "	Lead Control Level 2 (1 @ 2 mL)

## Reason for recall

Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.

## Distribution

Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan, Bolivia, Canada, Chile, Diego Garcia, Ecuador, Eritrea, Georgia, Ghana, Guam, Guatemala, Haiti, Hong Kong, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kyrgyzstan, Mexico, Nepal, Peru, Philippines, South Africa, South Korea, Spain, UAE, Uruguay, Vietnam.

## Key facts

- **Recall number:** Z-1893-2026
- **Recalling firm:** Magellan Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-13
- **Report date:** 2026-04-29

- **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-1893-2026

## Citation

> AI Analytics. FDA recall Z-1893-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1893-2026. Source: US FDA. Licensed CC0.

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