July 13 (Reuters) - The U.S. Food and Drug Administration on Thursday raised concerns about Meridian Bioscience Inc’s facility that manufactures its testing device nearly two months after the regulator warned the tests underestimate lead levels in blood.
The FDA issued a Form 483 to Magellan Diagnostics, which was bought by Meridian Bioscience in 2016 for $66 million, noting that the design validation does not ensure the device conforms to defined user needs.
In May, the regulator warned laboratories and healthcare professionals not to use any lead testing device made by the company to test blood drawn from veins.
In the Form 483 on Thursday, FDA also noted that the company failed to adequately evaluate the risk of the test for falsely low results. (bit.ly/2udKvM8)
If the agency finds problems in company facilities, it issues a Form 483 — a notice outlining violations — which if not resolved can lead to a “warning letter” and in worst case, a ban. (Reporting by Divya Grover in Bengaluru; Editing by Shounak Dasgupta)