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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Medical Device Notification: Data Innovations Instrument Manager-Data Innovations, Inc.

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.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002