Cytomics MXP Software, Version 1.0, Part No. 623688.
FDA device recall Z-0636-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print format, will have the fixed Sample ID and Run Date, rather than the correct Sample ID and Run Date.
- Action taken
- Firm sent modified operating instructions to users on 13 February 2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKL
- Quantity affected
- 7
- Distribution
- Nationwide and Canada
- Date initiated
- 2004-02-13
- Date posted
- 2004-07-20
- Date terminated
- 2012-05-08
- Location
- Brea, CA
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