Medical Device Notification
Data Innovations Instrument Manager
DATE NOTIFICATION INITIATED:
September 19, 2007
PRODUCT:
Data Innovations Instrument Manager - Software versions 7.04.0001 through 8.04.03.01
MANUFACTURER:
Data Innovations, Inc.
South Burlington, Vermont
REASON:
Corrupt database indices in the Specimen Management database could cause the misassociation of test and test result for a specific specimen(s). Customers are requested to download the repair utility from the manufacturer's website.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.