Atlas FDA

DL 2000 Data Manager, Software Version 6.2

FDA device recall Z-1027-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm
Beckman Coulter Inc
Reason for recall
Software defect. The type of results affected were replicate type results for a single sample transmitted within the same data stream.
Action taken
Recall is complete. Letters were mailed to customers on 2/14/2003. Instruments received upated software version 6.3.
Root cause
Other
Status
Terminated
Quantity affected
231
Distribution
Nationwide.
Date initiated
2004-02-14
Date posted
2004-07-20
Date terminated
2004-12-02
Location
Brea, CA

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