Official recall notice
FDA DeviceClass IINotable
FDA Recall: LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided wi
- Recall date
- 2026-04-29
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
136
Product 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.