FDA Medical Device Recalls (openFDA)
Misys Healthcare Systems: Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI Version 5.3
- Recall number
- Z-0678-03
- Recalling firm
- Misys Healthcare Systems
- Product
- Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI Version 5.3
- Status
- Terminated
- Initiated
- 2003-01-17
- Posted
- 2003-03-26
- Terminated
- 2004-05-07
- Reason
- Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol.
- Root cause
- Other
- Action
- Firm sent notice by fax on 1/17/2003. The notice includes information about an effective workaround and indicates that the firm will announce the availability of a software correction when it''s ready.
- Quantity
- 520
- Distribution
- Nationwide and to United Kingdom, Ireland, Canada, Denmark, Saudi Arabia, United Arab Emirates.
- Lot, serial or model codes
- Version 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