Data Innovations, Inc. Roche Modular Drive (rchmdlri), analytical laboratory data interface. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche Modular Drive (rchmdlri), analytical laboratory data interface.
Brand
Data Innovations, Inc.
Lot Codes / Batch Numbers
Software Version: v8.00.0016, v8.00.0017, v7.00.0023 and v7.00.0024
Products Sold
Software Version: v8.00.0016, v8.00.0017, v7.00.0023 and v7.00.0024
Data Innovations, Inc. is recalling Roche Modular Drive (rchmdlri), analytical laboratory data interface. due to Software of modular driver may incorrectly report patient results as Quality Control Results. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software of modular driver may incorrectly report patient results as Quality Control Results
Recommended Action
Per FDA guidance
Data Innovations notified users by email listserv and by letter dated 10/25/06.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026