Biosite, Inc. - May 8, 2009
Issue Date
May 08, 2009
Region
Pacific
Category
Device
$117.00
Address 1
9975 Summers Ridge Rd.
City
San Diego
State
CA
Zip/Postal Code
92121
Country
US
Inspection Range
Apr 28, 2009 - May 08, 2009
Pages
3
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 has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Yvette E. Guillermo