Recalls / —

—#29867

Product

Synchron CX4, CX5 and CX9 Pro Systems.

FDA product code

JQP — Calculator/Data Processing Module, For Clinical Use

Device class

Class 1

Medical specialty

Clinical Chemistry

510(k) numbers

K011465, K951189

Affected lot / code info

NA

Why it was recalled

Motor driver boards may contain wrong type of microchip which does not have obstruction detection feature.

Root cause (FDA determination)

Other

Action the firm took

Product Corrective Action letter was sent the week of 9/29/2003 by US MAIL with a fax back card.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 South Kraemer Blvd, Brea, California 92821

Distribution

Distribution pattern

Nationwide and Canada

Timeline

Recall initiated

2003-09-29

Posted by FDA

2003-10-24

Terminated

2004-04-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #29867. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.