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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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448