Skip to main content
Recall Canary
Magellan Diagnostics LeadCare II Blood Lead Test Kits
← Back to all recalls
MEDICAL DEVICE RECALLMODERATE

Magellan Diagnostics LeadCare II Blood Lead Test Kits

Magellan Diagnostics is recalling LeadCare II blood lead test kits due to the risk of false positive results.

What to do

Stop using the affected test kits with third-party micro-collection devices and contact Magellan Diagnostics for further instructions regarding testing procedures.

Posted
Updated
Recall No.
Z-1893-2026
Agency
Firm
Magellan Diagnostics, Inc.
Recall ID
98502
Status
ONGOING

Why it was recalled

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.

How to identify it

UPC 00850355006000 00850355006086 00850355006093

Where it was sold

Distributed in US.

← Back to all recalls

Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification