fda_recall · device_recall · high
Magellan Diagnostics, Inc. — Class II recall: LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultr…
- Event date
- 2026-04-29 00:00:00Z
- Observed
- 2026-07-09 22:52:57Z
- Source ID
- Z-1895-2026
- Payload hash
- 45f0abe47a69a83b089902be…
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.
Entities
Informational only. Not legal, financial, or medical advice.