FDA Medical Device Recalls (openFDA)
Sunquest Information Systems: Misys Laboratory versions 5.23 and 5.3 with Callback
- Recall number
- Z-0324-03
- Recalling firm
- Sunquest Information Systems
- Product
- Misys Laboratory versions 5.23 and 5.3 with Callback
- Status
- Terminated
- Initiated
- 2002-10-18
- Posted
- 2002-12-05
- Terminated
- 2004-12-01
- Reason
- Software anomally - animal ranges, when desired on reports, are defaulting to human male ranges.
- Root cause
- Other
- Action
- Notice of recall was sent by fax on October 18, 2002. A software fix will be available for version 5.3 in January 2003. Users will be notified again of this new release and be urged to update from version 5.23 to version 5.3. Completion of the recall is estimated to be in March 2003.
- Quantity
- 463
- Distribution
- Nationwide and to the United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, and United Arab Emirates,
- Lot, serial or model codes
- Versions 5.23 and 5.3 with Callback.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- not on file
- 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