Fresh Recalls

LeadCare Ultra Blood Lead Test Kit: recall status

Notice names this product. Magellan Diagnostics’s LeadCare Ultra Blood Lead Test Kit is named in FDA Class II recall Z-1895-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: Catalog Number: 70-8098; UDI-DI: 00850355006024; ALL lots and ALL sublots;. Units affected: 284. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
LeadCare Ultra Blood Lead Test Kit
Company / brand
Magellan Diagnostics
Lot / serial / date codes
Catalog Number: 70-8098; UDI-DI: 00850355006024; ALL lots and ALL sublots;
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.
Agency product description and boundaries

LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand
Magellan Diagnostics

Recalls naming this model

FDA Class II · Medical device · April 29, 2026

LeadCare Ultra Blood Lead Test Kit recall — Magellan Diagnostics, Inc.

Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test S…

Company / brand: Magellan Diagnostics recalls

Affected product: LeadCare Ultra Blood Lead Test Kit recall status

Official ID Z-1895-2026 · Official record ↗

See all Magellan Diagnostics recalls →

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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.