—#28262

Product

Synchron LX Systems Primary Tube Sample Template (a piece of ''labeling'' for use with the Synchron LX 20 and LX 20 Pro systems). Part Number: 967178

Affected lot / code info: No range of serial numbers apply.

Why it was recalled

Dead volume on sight gauge for the Synchron LX 20 and LX 20 Pro Systems not stated, which may result in instrument error.

Root cause (FDA determination)

Other

Action the firm took

A revised template with a recall letter was sent to customers with a response request on 19 June 2003.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 South Kraemer Blvd W, 337, Brea, California 92822

Distribution

Distribution pattern: USA and Canada.

Timeline

Recall initiated: 2003-06-19
Posted by FDA: 2003-08-06
Terminated: 2004-12-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #28262. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.