Magellan Diagnostics, Inc. - June 29, 2017
Issue Date
Jun 29, 2017
Region
Northeast
Category
Device
$117.00
Contact Name
Amy M. Winslow
Contact Title
President and CEO
Address 1
101 Billerica Ave.
Address 2
Bldg. 4
City
North Billerica
State
MA
Zip/Postal Code
01862
Country
United States
Inspection Range
May 10, 2017 - Jun 29, 2017
Pages
10
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Suzanne M. Healy, Ian A. Pilcher, and James W. Whitney