Misys Laboratory with Lab Access Results application for versions 5.3 and later.
This recall has been terminated (originally issued June 28, 2005).
- Company
- Misys Healthcare Systems
- Recall Initiated
- May 13, 2005
- Posted
- June 28, 2005
- Terminated
- February 10, 2006
- Recall Number
- Z-0938-05
- Quantity
- 258
- Firm Location
- Tucson, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
Software anomaly may rarely allow modification of previously reported specimen results.
Distribution
Nationwide and United Kingdom, Ireland, Denmark, Canada, Saudi Arabia, United Arab Emirates
Lot / Code Info
Versions 5.3 and later.
Root Cause
Other
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.
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