On July 13, 2017, the FDA updated the Class I recall issued for all serial numbers and all lot numbers of LeadCare Plus and Ultra Testing Systems. Magellan’s LeadCare Plus and Ultra Testing Systems were two of four blood lead testing systems affected by recommendations in an FDA safety communication.
On March 25, 2017, Magellan Diagnostics recalled the LeadCare Plus and the LeadCare Ultra Testing Systems because they may underestimate the blood lead levels (BLL) and give inaccurate results when processing venous blood samples. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning. Use of the recalled product may cause serious adverse health consequences.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
At the time of the initial recall, the FDA was unable to identify the root cause of the inaccurate results based on data provided by Magellan. The FDA is conducting studies with the CDC to identify the cause and better characterize the extent of the problem.
As part of the FDA’s investigation, it inspected Magellan Diagnostics’ facility in North Billerica, Massachusetts. On July 13, 2017, the FDA released the report issued at the conclusion of the inspection, which included several inspectional observations that may be violations of federal law. The FDA began to review the evidence collected during the inspection to determine if there had been violations of federal law and whether further action was warranted.
See the FDA Announcement
See the FDA Safety Alert
See also Medical Law Perspectives Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks