fda_recall · device_recall · high
Magellan Diagnostics, Inc. — Class II recall: (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit,…
- Event date
- 2026-04-29 00:00:00Z
- Observed
- 2026-07-09 22:52:55Z
- Source ID
- Z-1893-2026
- Payload hash
- e2245fdd48cc8d73ca4ce04f…
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.