Recalls / —

—#29546

Product

Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604

FDA product code

GKZ — Counter, Differential Cell

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K992511

Affected lot / code info

All instruements are affected.

Why it was recalled

Samples with high fat content will not count platelets accurately.

Root cause (FDA determination)

Other

Action the firm took

Firm issued an advisory letter to users to retain as part of the Quality Manual for the instruments. It cautions to check specimens for interfering lipemia. Letter was sent 9/8/2003.

Recalling firm

Firm

Beckman Coulter Inc

Address

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

Distribution

Distribution pattern

United States and Canada

Timeline

Recall initiated

2003-09-08

Posted by FDA

2003-10-15

Terminated

2004-03-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #29546. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.