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Diabetes Notes

Johnson & Johnson warned by the FDA

by Maruthi on December 21st, 2005

The Food and Drug Administration (FDA) has sent a warning letter to LifeScan Inc, a unit of Johnson & Johnson for not adequately reporting problems associated with its meters used for blood-glucose tests. The problem with the meters is that you could accidentally change the unit of measurement and hence end up interpreting the test results wrong. Though the company informed its users of the problem and the ways to fix it, and also redesigned the devices, it failed to properly investigate and report the complaints to the FDA. As per the rules, companies need to report any serious problem associated with their devices to the FDA. The FDA is waiting for reports on the investigation of complaints on returned glucose meters from LifeScan.

via Yahoo! News

POSTED IN: News

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