Haemoscope Division of Haemonetics Corp. - May 24, 2013
Issue Date
May 24, 2013
Region
Central
Category
Device
$117.00
Address 1
6231 W Howard St.
City
Niles
State
IL
Zip/Postal Code
60714-3403
Country
US
Inspection Range
Apr 29, 2013 - May 24, 2013
Pages
4
First Observation
Software used as part of the quality system has not been adequately validated for its intended use according to an established protocol.
Investigator(s): Paola S. Barnett and Jesse A. Vazquez