Recalls / —

—#35841

Product

DL2000 Data Manager Software, Version 6.4.108

FDA product code

JQP — Calculator/Data Processing Module, For Clinical Use

Device class

Class 1

Medical specialty

Clinical Chemistry

Affected lot / code info

Version 6.4.108

Why it was recalled

Possibility of reporting an incorrect result occurs due to a software anomally.

Root cause (FDA determination)

Other

Action the firm took

Letters were sent to sites on November 5, 2004 to confirm previous telephone conversations with the consignees.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern

Product was under evaluation at three sites in FL, IL, and CA.

Timeline

Recall initiated

2004-11-05

Posted by FDA

2004-11-30

Terminated

2005-03-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #35841. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.