FDA Medical Device Recalls (openFDA)
Sunquest Information Systems: Misys Laboratory, version 5.3 with Reference Laboratory Interface
- Recall number
- Z-0647-03
- Recalling firm
- Sunquest Information Systems
- Product
- Misys Laboratory, version 5.3 with Reference Laboratory Interface
- Status
- Terminated
- Initiated
- 2002-10-18
- Posted
- 2003-03-13
- Terminated
- 2004-12-03
- Reason
- Software anomaly, incorrect coding. Some comments were not transfered when coming from the Reference Laboratory Interface.
- Root cause
- Other
- Action
- A product workaround was communicated to the two affected sites by facsimile on October 18, 2002. The recall is complete.
- Quantity
- 2
- Distribution
- States of WI, and IL.
- Lot, serial or model codes
- Version 5.3 with Reference Laboratory Interface
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 1000306472
- Firm city
- Tucson
- Firm state
- AZ
- 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