Search Results for LeadCare

Showing 1 – 2

FDA: Lead Test Company May Have Violated Federal Law By Michael Mezher - Published 13 July 2017

The US Food and Drug Administration (FDA) on Thursday said that lead test maker Magellan Diagnostics may have violated federal law in its handling of customer complaints and design validation for its LeadCare testing systems.

Categories: News, US, CDRH, In vitro diagnostics

Tags: LeadCare, Lead Testing, Magellan Diagnostics, Form 483

FDA Warns of False Results With Common Lead Test By Michael Mezher - Published 17 May 2017

In the wake of a lead contamination crisis affecting cities across the country, the US Food and Drug Administration (FDA) on Wednesday warned that a commonly used line of lead testing systems may provide falsely low results under certain circumstances.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices

Tags: Lead, Magellan Diagnostics, LeadCare