Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation.
FDA device recall Z-1093-03 · posted 2003-08-07 · Terminated
Recall details
- Recalling firm
- Misys Healthcare Systems
- Reason for recall
- Software defect. When Quality Assurance failure warnings are missing from a patient's report abnormal results could be used for diagnosis or treatment.
- Action taken
- Recall notice, PSN-03-L30, was sent by fax on 6-23-2003.. nb. Firm requests the afforementioned sentence be placed in the ER.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 157
- Distribution
- Nationwide and to United Kingdom, Ireland, Canada, Denmark, Saudi Arabia, United Arab Emirates.
- Date initiated
- 2003-06-23
- Date posted
- 2003-08-07
- Date terminated
- 2004-04-23
- Location
- Tucson, AZ
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