FDA Medical Device Recalls (openFDA)
Data Innovations, Inc.: 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)
- Recall number
- Z-0167-2007
- Recalling firm
- Data Innovations, Inc.
- Product
- 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)
- Status
- Terminated
- Initiated
- 2006-08-10
- Posted
- 2006-11-14
- Terminated
- 2016-02-22
- Reason
- Patient results may be associated with an incorrect specimen
- Root cause
- Other
- Action
- 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.
- Quantity
- 187
- Distribution
- Worldwide distribution (USA and Canada)
- Lot, serial or model codes
- Software Versions: 8:00, 8.01, 8.02, 8.03 or 8.04
- 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