FDA Medical Device Recalls (openFDA)
Data Innovations, Inc.: Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
- Recall number
- Z-0083-2012
- Recalling firm
- Data Innovations, Inc.
- Product
- Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
- Status
- Terminated
- Initiated
- 2009-05-11
- Posted
- 2011-10-21
- Terminated
- 2011-10-25
- Reason
- The "previous result" retrieved from the Specimen Management Database may not be the most recent "previous result".
- Root cause
- Software design
- Action
- Data Innovations sent an "IMPORTANT PRODUCT NOTICE" dated May 11, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter offers temporary workarounds for customers to use until corrected versions of the software is complete. Versions of the corrections will be provided on a staggered schedule. Customers will be notified by e-mail. Questions regarding this notice are directed to Support at 802-658-1955.
- Quantity
- 188
- Distribution
- USA (nationwide) and the country of Canada.
- Lot, serial or model codes
- S/W Versions 8.05, 8.06, 8.07, 8.08 and 8.09.
- 510(k) numbers
- ["BK080052"]
- 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