Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results
FDA device recall Z-1217-03 · posted 2003-09-11 · Terminated
Recall details
- Recalling firm
- Misys Healthcare Systems
- Reason for recall
- Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported.
- Action taken
- Product Safety Notice, PSN-03-L04 was issued to all affected customers by fax on 07/22/2003. This included a procedural workaround to use until a software correction is made available or to use indefinitly at the user''s discretion. Completion of the recall , including release of the software fix is expected in December 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 171
- Distribution
- Nationwide and to United Kingdom, Canada, Denmark, Ireland, Saudi Arabia, United Arab Emirates.
- Date initiated
- 2003-07-22
- Date posted
- 2003-09-11
- Date terminated
- 2004-06-25
- Location
- Tucson, AZ
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