Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 15 User Pack, Automa
FDA device recall Z-2022-2008 · posted 2008-07-11 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Incorrect Display: In certain modes, the protocol will not initially display the correct data in some plots. In addition, when running EWL files, any edited SampleID1 is not automatically updated in all tubes in the panel.
- Action taken
- Consignees were notified of this safety recall by an Urgent Product Corrective Action letter sent on 5/3/07. The letter provided instructions on how to ensure correct data acquisition. Users were requested to return a response form acknowledging receipt of the letter. For additional information contact 1-800-526-7694.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 445 units in the US; 56 units in Canada
- Distribution
- Worldwide Distribution including USA and country of Canada.
- Date initiated
- 2007-05-04
- Date posted
- 2008-07-11
- Date terminated
- 2011-07-11
- Location
- Brea, CA
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