FDA Medical Device Recalls (openFDA)
Misys Healthcare Systems: Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results.
- Recall number
- Z-0238-04
- Recalling firm
- Misys Healthcare Systems
- Product
- Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results.
- Status
- Terminated
- Initiated
- 2003-07-21
- Posted
- 2004-07-20
- Terminated
- 2004-11-15
- Reason
- Incorrect demographics display which can result in incorrect information being used in diagnosis or treatment of patients.
- Root cause
- Other
- Action
- A temporary procedural workaround was communicated by fax to customers in Product Safety Notice PSN-03-L33 on July 21, 2003. Asecond Notice (L33A) was sent to customers to futher facilitate the recall.
- Quantity
- 125
- Distribution
- Nationwide, Canada, Saudi Arabia, United Kingdom.
- Lot, serial or model codes
- Version 5.3 build 63 thru 6.3.2 and LabAccess Results.
- 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