DL 2000 Data Manager, Software Version 6.2
FDA Recall Z-1027-04 · Posted 2004-07-20
Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Date Initiated2004-02-14
Date Terminated2004-12-02
Product Quantity231
Reason for Recall
Software defect. The type of results affected were replicate type results for a single sample transmitted within the same data stream.
Firm Action
Recall is complete. Letters were mailed to customers on 2/14/2003. Instruments received upated software version 6.3.
Root Cause
Other
Distribution Pattern
Nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.