FDA Medical Device Recalls (openFDA)
Misys Healthcare Systems: Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results
- Recall number
- Z-1217-03
- Recalling firm
- Misys Healthcare Systems
- Product
- Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results
- Status
- Terminated
- Initiated
- 2003-07-22
- Posted
- 2003-09-11
- Terminated
- 2004-06-25
- Reason
- Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported.
- Root cause
- Other
- Action
- Product Safety Notice, PSN-03-L04 was issued to all affected customers by fax on 07/22/2003. This included a procedural workaround to use until a software correction is made available or to use indefinitly at the user''s discretion. Completion of the recall , including release of the software fix is expected in December 2003.
- Quantity
- 171
- Distribution
- Nationwide and to United Kingdom, Canada, Denmark, Ireland, Saudi Arabia, United Arab Emirates.
- Lot, serial or model codes
- Version 5.2 through 5.3.2 using 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