FDANews
FDAnews Device Daily Bulletin

Good News, Bad News for BD: OK on Lead Tests, But Other Problems, FDA Says

Aug. 23, 2017

The FDA said it could find no evidence that tubes made by Becton Dickinson for Magellan Diagnostics’ blood lead-level testing devices contributed to inaccurate readings from the devices, which Magellan had suggested as a cause.

But the agency cited several other problems discovered in an inspection of BD’s plant in Franklin Lakes, New Jersey earlier this year.

The FDA said the inspection is not a final determination that the tubes are not responsible for the inaccurate results.

View today's stories