Beckman Coulter Inc Access Power Supply Assembly Sled Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System, for in vitro diagnostic use. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Electrical grounding failure: During manufacturing, internal testing found one instrument wlth an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate soldering.

Recommended Action

Per FDA guidance

Beckman Coulter mailed a Product Corrective Action (PCA) letter on October 17, 2007 to all Access and Access 2 lmmunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System customers. The customers were informed that during manufacturing, internal testing found one instrument wlth an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate soldering. The letter referenced a proactive initiative to inspect the power supply sled assemblies on all instruments referenced. A response form was included.