Recalls / —

—#33125

Product

Customized Automation Centrifuge, First and Second Generation.

FDA product code

JQC — Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Device class

Class 1

Medical specialty

Clinical Chemistry

Affected lot / code info

First Generation: OPIC0004, HAND0007, HAND0008, HAND0011, HAND0012, U9507151, U9507152, U9507153.  Second Generation: 2028, 2030, 2032, 2033, 2034, 2038, 2039, 2040.

Why it was recalled

Centrifuge loss of containment with potential for injury or exposure to biohazard among lab workers.

Root cause (FDA determination)

Other

Action the firm took

Recall was by letter and by telephone. All customers have been contacted.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2004-05-06

Posted by FDA

2004-07-20

Terminated

2004-11-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #33125. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.