Here's what parents should know. The inaccurate results came from three Magellan devices: LeadCare Ultra, LeadCare II and LeadCare Plus. One, the LeadCare II, uses finger-stick samples primarily ...

The malfunctioning devices, LeadCare II and LeadCare Ultra, were used to test lead levels in blood from 2013 to 2017. A Bonita Springs resident and former chief operating officer of Magellan ...

The charges concern three devices produced by Magellan: LeadCare Ultra, LeadCare II, and LeadCare Plus. They are used to detect lead levels and lead poisoning in blood using either fingerstick ...

Magellan Diagnostics is headquartered in Billerica. Their devices — LeadCare Ultra, LeadCare II, and LeadCare Plus — were designed to detect lead levels in the blood of children and adults.

Magellan Diagnostics’ former CEO Amy Winslow pleaded guilty on 11 March to concealing device malfunctions in the company’s LeadCare lead detection tests that led to inaccurately low blood lead ...

The blood is combined with a “lysing agent” that separates lead from red blood cells, and the resulting liquid is dripped onto a sensor and inserted into LeadCare II. Three minutes later, ...

Magellan, a Meridian Bioscience business, admitted to misleading customers and the FDA about a serious malfunction in its LeadCare devices, which test venous blood samples. The devices produced ...

Magellan Diagnostics has admitted that it misled its customers and the Food and Drug Administration about a serious malfunction in its “LeadCare” devices, which “caused an estimated tens of ...

LeadCare Plus and LeadCare Ultra, meanwhile, were predominantly used to test venous samples.According to prosecutors, Magellan first learned that a malfunction in its LeadCare Ultra device could ...