Recalls / —

—#32883

Product

DataLink 2000 Data Manager

Affected lot / code info

Version 6.3

Why it was recalled

Software anomaly allows results to be archived prior to validation or to be uploaded to the lab information system.

Root cause (FDA determination)

Other

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Timeline

Recall initiated

2003-11-03

Posted by FDA

2004-07-28

Terminated

2004-08-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #32883. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.