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FDA warns Meridian of violations for lead-testing devices

FDA warns Meridian of violations for lead-testing devices
From Reuters - October 23, 2017

(Reuters) - The U.S. Food and Drug Administration said on Monday it issued a warning letter to Meridian Bioscience Incs unit for several federal law violations after inspecting its facility that makes lead-testing devices.

The violations include selling significantly modified versions of two of its blood lead-testing systems without the FDAs approval and failing to submit reports on the medical device after customer complained about discrepancies in the test results.

The U.S. regulator in July issued Meridians unit, Magellan Diagnostics, a Form 483 for its North Billerica, Massachusetts-based facility, nearly two months after it warned that the tests may underestimate lead levels in blood.

A Form 483 outlines violations in the companys facilities, which if not resolved lead to a warning letter and in worst case, a ban.

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