FDA Medical Device Recalls (openFDA)
Misys Healthcare Systems: Misys Laboratory System, versions 5.2, 5.23 and 5.3
- Recall number
- Z-1007-03
- Recalling firm
- Misys Healthcare Systems
- Product
- Misys Laboratory System, versions 5.2, 5.23 and 5.3
- Status
- Terminated
- Initiated
- 2003-06-10
- Posted
- 2003-07-15
- Terminated
- 2004-04-23
- Reason
- Software anomally Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal designations.
- Root cause
- Other
- Action
- Notification was sent by fax under Product Safety Notice, PSN-03-L27 on June 10, 2003 also under PSN-03-L27 on June 13, 2003 to sites with MIM functionality.
- Quantity
- 467
- Distribution
- Nationwide and to Ireland, Canada, Denmark, Bermuda, UK, Saudi Arabia, United Arab Emirates.
- Lot, serial or model codes
- Versions 5.2, 5.23 and 5.3
- 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