—#86317

Product

UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with Dxl System Software versions 4.2 or 4.2.1. In vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentrations found in human body fluids.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K023764, K060256
Affected lot / code info: DxI software versions: 4.2 and 4.2.1. For labeling see UniCel DxI Operator's Guide. Part Number: 387262G

Why it was recalled

This recall was initiated because of software issue was identified in System Software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. Instead of generating a red warning event and stopping sample processing, the system will post a yellow caution event and continue to operate with the dispense plate in an elevated position until the instrument

Root cause (FDA determination)

Software design

Action the firm took

Beckman Coulter issued an "Urgent: Product Corrective Action" letter dated October 28, 2009. Customers were notified of the affected product and how the issue will be resolved. For further information, contact Beckman Coulter Inc. Technical Support at 1-800-854-3633.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: Worldwide Distribution -- United States and Canada.

Timeline

Recall initiated: 2009-10-28
Posted by FDA: 2010-02-25
Terminated: 2012-05-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86317. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.