Cytomics FC500 with CXP Software
FDA device recall Z-0380-06 · posted 2006-01-11 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0
- Action taken
- A Product Corrective Action letter will be mailed the week of Nov 28, 2005 to all FC500 wi CXP Software customers. Each user will be contacted initially and then once more (if needed) in order to determine the rate of response from the Response form provided.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- JJF
- Quantity affected
- 179
- Distribution
- Nationwide and Canada
- Date initiated
- 2005-11-23
- Date posted
- 2006-01-11
- Date terminated
- 2012-01-26
- Location
- Brea, CA
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