Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0
FDA device recall Z-1377-05 · posted 2005-08-17 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- 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.
- Action taken
- Letters issued to users on July 13, 2005 which also included modified operating instructions, and response cards.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 36
- Distribution
- USA
- Date initiated
- 2005-07-06
- Date posted
- 2005-08-17
- Date terminated
- 2012-04-26
- Location
- Brea, CA
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