fda_recall · device_recall · high

Magellan Diagnostics, Inc. — Class II recall: LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plu…

Event date
2026-04-29 00:00:00Z
Observed
2026-07-09 22:52:54Z
Source ID
Z-1894-2026
Payload hash
a6724101c540f625b109040f

Summary

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. Status: Ongoing.

Informational only. Not legal, financial, or medical advice.