Recalls / —

—#25654

Product

SYNCHRON LX20 AND LX20 Pro

FDA product code

JGS — Electrode, Ion Specific, Sodium

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K011213, K014034, K965240

Affected lot / code info

All serial numbers.

Why it was recalled

The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence.

Root cause (FDA determination)

Other

Action the firm took

Firm will inspect instruments for failure conditions and fix the problem.

Recalling firm

Firm

Beckman Coulter Inc

Address

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

Distribution

Distribution pattern

Canada and USA.

Timeline

Recall initiated

2002-12-16

Posted by FDA

2003-02-05

Terminated

2004-12-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25654. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.