FDA Medical Device Recalls (openFDA)
Misys Healthcare Systems: Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation.
- Recall number
- Z-1093-03
- Recalling firm
- Misys Healthcare Systems
- Product
- Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation.
- Status
- Terminated
- Initiated
- 2003-06-23
- Posted
- 2003-08-07
- Terminated
- 2004-04-23
- Reason
- Software defect. When Quality Assurance failure warnings are missing from a patient's report abnormal results could be used for diagnosis or treatment.
- Root cause
- Other
- Action
- Recall notice, PSN-03-L30, was sent by fax on 6-23-2003.. nb. Firm requests the afforementioned sentence be placed in the ER.
- Quantity
- 157
- Distribution
- Nationwide and to United Kingdom, Ireland, Canada, Denmark, Saudi Arabia, United Arab Emirates.
- Lot, serial or model codes
- Versions 5.3 up to 5.3.2.
- 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