Misys Laboratory with Lab Access Results application for versions 5.3 and later.
FDA device recall Z-0938-05 · posted 2005-06-28 · Terminated
Recall details
- Recalling firm
- Misys Healthcare Systems
- Reason for recall
- Software anomaly may rarely allow modification of previously reported specimen results.
- Action taken
- Product Safety Notice PSN-05-01 was sent by fax on May 13, 2005 and includes a procedural work-around to avoid the defect until the firm is able to provide a software patch.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 258
- Distribution
- Nationwide and United Kingdom, Ireland, Denmark, Canada, Saudi Arabia, United Arab Emirates
- Date initiated
- 2005-05-13
- Date posted
- 2005-06-28
- Date terminated
- 2006-02-10
- Location
- Tucson, AZ
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