FDA Medical Device Recalls (openFDA)
Misys Healthcare Systems: Misys Laboratory System Version 5.3
- Recall number
- Z-0646-03
- Recalling firm
- Misys Healthcare Systems
- Product
- Misys Laboratory System Version 5.3
- Status
- Terminated
- Initiated
- 2003-02-06
- Posted
- 2003-03-13
- Terminated
- 2004-05-07
- Reason
- Two customers report that the organism identified on the patient's lab file do not match the reported susceptibility battery.
- Root cause
- Other
- Action
- Firm notified customers by fax on 2/6/2003. This included a workaround procedure. A correcting software package will be created and announced at a later date. Estimated completion date is May 1, 2003
- Quantity
- 465
- Distribution
- Nationwide and to United Kingdom, Ireland, Canada, Denmark, Bermuda, 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