—#67172

Product

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.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K023049, K060256, K922823
Affected lot / code info: Part Number A48196/6845C; Instrument part numbers 81600 and 81600N

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Nationwide Distribution and Canada

Timeline

Recall initiated: 2007-10-17
Posted by FDA: 2008-08-20
Terminated: 2012-04-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67172. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.