Magellan Recalls LeadCare Test Systems

FDA says the Magellan Diagnostics recall of all lots of its LeadCare and LeadCare II blood lead testing systems manufactured between 9/2013 and the present and distributed between 1/1/14 and 5/22/17 is a Class 1 recall. The company expanded its LeadCare Plus and Ultra Testing Systems recall to include the two additional systems. An FDA notice says the systems may underestimate the blood lead levels and give inaccurate results when processing venous blood samples.

The recall accompanies an agency 5/17 safety communication that affected the two Magellan systems and two others. “FDA is unable to identify the root cause for the inaccurate results, based on data provided by Magellan,” the notice says. “We are conducting studies with the Centers for Disease Control and Prevention to identify the cause and better characterize the extent of the problem.”