FDA Medical Device Recalls (openFDA)
Data Innovations, Inc.: Roche Modular Drive (rchmdlri), analytical laboratory data interface.
- Recall number
- Z-0223-2007
- Recalling firm
- Data Innovations, Inc.
- Product
- Roche Modular Drive (rchmdlri), analytical laboratory data interface.
- Status
- Terminated
- Initiated
- 2006-11-03
- Posted
- 2006-11-29
- Terminated
- 2015-06-11
- Reason
- Software of modular driver may incorrectly report patient results as Quality Control Results
- Root cause
- Software change control
- Action
- Data Innovations notified users by email listserv and by letter dated 10/25/06.
- Quantity
- 56
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- Software Version: v8.00.0016, v8.00.0017, v7.00.0023 and v7.00.0024
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 3001451449
- Firm city
- South Burlington
- Firm state
- VT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28