Haemoscope Corp. - September 9, 2010
Issue Date
Sep 09, 2010
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
Sep 01, 2010 - Sep 09, 2010
Pages
2
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Joseph A. Morkunas