Atlas FDA

CXP software, Part No. 623560, version 1.0

FDA device recall Z-0635-04 · 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
21
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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