Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results
This recall has been terminated (originally issued September 11, 2003).
- Company
- Misys Healthcare Systems
- Recall Initiated
- July 22, 2003
- Posted
- September 11, 2003
- Terminated
- June 25, 2004
- Recall Number
- Z-1217-03
- Quantity
- 171
- Firm Location
- Tucson, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported.
Distribution
Nationwide and to United Kingdom, Canada, Denmark, Ireland, Saudi Arabia, United Arab Emirates.
Lot / Code Info
Version 5.2 through 5.3.2 using LabAccess Results
Root Cause
Other
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.
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