Misys Laboratory System versions 5.23 and 5.3
FDA device recall Z-0791-03 · posted 2003-05-08 · Terminated
Recall details
- Recalling firm
- Misys Healthcare Systems
- Reason for recall
- With SMART enabled, for an accession number with multiple tests, credits and additions, the system may delete and reorder resulted tests.
- Action taken
- The firm faxed notification on 3/26/2003 along with a response form and a temporary procedural workaround in Product Safety Notice PSN-03-L13.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 463
- Distribution
- Nationwide and to United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, United Arab Emirates.
- Date initiated
- 2003-03-26
- Date posted
- 2003-05-08
- Date terminated
- 2004-04-21
- Location
- Tucson, AZ
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