Skip to main content
Premium Trial:

Request an Annual Quote

Magellan Dx May Have Broken Law With Blood Lead-Poisoning Tests, FDA Says

NEW YORK (360Dx) – The US Food and Drug Administration on Thursday said that blood lead-poison testing conducted at a Magellan Diagnostics facility may have violated federal law.

In a statement, Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiologic Health at FDA's Center for Devices and Radiologic health, said that during an inspection of the facility in Billerica, Massachusetts, the agency made "several observations that may be violations of federal law. We are carefully reviewing the evidence collected during the inspection to determine if there have been violations of federal law and whether further action is warranted."

The inspection followed a recall of Magellan's lead-poisoning tests and test systems in May after the FDA and the US Centers for Disease Control and Prevention determined that some test results were inaccurate. The recall was expanded in June to include additional lead testing systems from Magellan, a business of Meridian Bioscience.

The issue has also gotten the attention of some senators, and two weeks ago a dozen legislators asked the FDA and the CDC for clarity around the recall, and explain why for three years, the Magellan products continued to be used and why consumers continued to base healthcare decisions on possibly inaccurate results.

In a report published on Thursday detailing the inspection of the Billerica facility, the FDA identified nine issues surrounding Magellan's testing systems and how the company handled customer complaints and warnings about its lead-poisoning tests. For example, the agency determined that Magellan's risk analysis was inadequate and said that the firm "failed to identify potential risk to patients of a falsely low test result obtained by the LeadCare Ultra" Blood Lead Testing System, one of the recalled systems.

The FDA also said that Magellan did not adequately evaluate another system, the LeadCare II Blood Lead Testing System, for falsely low results.

In another observation, the FDA criticized the firm for not reporting in a timely manner information that indicated its LeadCare Ultra system had malfunctioned in a manner that, if repeated, could cause injury or death. A Magellan document stated that company procedures call for such malfunctions to be alerted to the FDA within 30 calendar days, but in the case of one customer complaint about a system malfunction, Magellan did not report the event to the agency for 201 calendar days.

It further noted that the company failed to report to the agency several "events involving underestimation of blood lead results from the LeadCare Ultra system."

In a statement, Meridian Bio said that the FDA inspection, which occurred between May 10 and June 29, represents the investigators' observations, and the report is not a final determination by the agency. Meridian will "promptly submit responses" to the FDA," it said, adding it and Magellan "take this very seriously and Magellan is addressing [FDA's] observations … with the highest sense of urgency."