—#29866

Product

Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems, Synchron LXi Systems.

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K011213, K014034, K023049, K965240
Affected lot / code info: All those with version 4.0 operating software.

Why it was recalled

Sample wheel may home to the wrong position.

Root cause (FDA determination)

Other

Action the firm took

Recall is accomplished by telephone and by letter. Telephone calls were made by 9/24/2003. All customers have been notified by telephone.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 South Kraemer Blvd, Brea, California 92821

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2003-09-18
Posted by FDA: 2003-11-06
Terminated: 2004-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #29866. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.