Atlas FDA

CXP software for Cytomics FC500 Cytometer

FDA device recall Z-0266-05 · posted 2004-11-30 · Terminated

Recall details

Recalling firm
Beckman Coulter Inc
Reason for recall
Incorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect.
Action taken
The Product Corrective Action Customer Letter which includes Modified Operating Instructions was sent to US and Canadian customers the week of November 8, 2004 via US Mail.
Root cause
Other
Status
Terminated
Product code
GKZ
Quantity affected
167
Distribution
Nationwide and Canada
Date initiated
2004-11-02
Date posted
2004-11-30
Date terminated
2012-05-08
Location
Brea, CA

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