FDA Device

Roche Modular Drive (rchmdlri), analytical laboratory data interface.

Hazard

Software of modular driver may incorrectly report patient results as Quality Control Results

What You Should Do

Remedy

Data Innovations notified users by email listserv and by letter dated 10/25/06.

Products

Roche Modular Drive (rchmdlri), analytical laboratory data interface.
Brand
Data Innovations, Inc.
UPC
Software Version: v8.00.0016, v8.00.0017, v7.00.0023 and v7.00.0024

Units Affected

56