FDA Issues Update on Magellan Diagnostics Recalled Blood Tests
The FDA has designated Magellan Diagnostics’s recall of certain lots of blood tests as Class 1, indicating a reasonable probability that the products could cause serious adverse health consequences or death.
The recalled products are 13 lots of the company’s LeadCare II, LeadCare Plus and LeadCare Ultra blood lead tests, which measure blood lead levels. The company issued recall notices for the products in late May and June.
The FDA said the blood tests “may provide falsely low results and may lead to health risks in special populations, such as young children and pregnant individuals.”