LeadCare® Plus Blood Lead Test KitRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K142705); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 13, 2026Open, Classified

   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.

   Z-1894-2026 · Root cause: Device Design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142705. One submission often covers many models, so check the product and lot details in each record.

• Z-1953-2021 · May 7, 2021 · Terminated
  LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
• Z-1296-2018 · Jan 9, 2018 · Terminated
  LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
• Z-1926-2017 · Nov 29, 2014 · Terminated
  Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010