Recalls / —

—#26918

Product

COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use

FDA product code

JQW — Station, Pipetting And Diluting, For Clinical Use

Device class

Class 1

Medical specialty

Clinical Chemistry

Affected lot / code info

All existing versions of the software.   Serial numbers PrepPlus 0006026440 and above PrepPlus 2 0109079674 and above

Why it was recalled

Software problem may cause the instrument to skip the probe-wash step before processing different reagents.

Root cause (FDA determination)

Other

Action the firm took

The firm sent notification letter and modified operating instructions by mail on March 28, 2003.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 South Kraemer Blvd W, 337, Brea, California 92822

Distribution

Distribution pattern

USA and Canada

Timeline

Recall initiated

2003-03-28

Posted by FDA

2003-05-09

Terminated

2003-10-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #26918. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.