FDA DeviceClass IINotable

FDA Recall: LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided wi

Date: 2026-04-29
Brand: Magellan Diagnostics, Inc.
Category: Medical Device
FDA Class: Class II

Description

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.

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.

Remedy

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