Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0
This recall has been terminated (originally issued August 17, 2005).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- July 6, 2005
- Posted
- August 17, 2005
- Terminated
- April 26, 2012
- Recall Number
- Z-1377-05
- Quantity
- 36
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Software anomally. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results.
Distribution
USA
Lot / Code Info
Versions 1.1 and 2.0
Root Cause
Other
Action Taken
Letters issued to users on July 13, 2005 which also included modified operating instructions, and response cards.
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