—#32830

Product

DL 2000 Data Manager, Software Version 6.2

Affected lot / code info: Version 6.2

Why it was recalled

Software defect. The type of results affected were replicate type results for a single sample transmitted within the same data stream.

Root cause (FDA determination)

Other

Action the firm took

Recall is complete. Letters were mailed to customers on 2/14/2003. Instruments received upated software version 6.3.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2004-02-14
Posted by FDA: 2004-07-20
Terminated: 2004-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #32830. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.