FDA Device

Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R)

Hazard

Patient results may be associated with an incorrect specimen

What You Should Do

Remedy

Data Innovations notified customers by an email listserv notification and by letter dated 8/17/06. A patch would be available on the website to be downloaded.

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Products

Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R)
Brand
Data Innovations, Inc.
UPC
Software Versions:  8:00, 8.01, 8.02, 8.03 or 8.04

Units Affected

187

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