—#107334

Product

Access Immunoassay Systems Assay Protocol File (APF) Software versions for Synchron LXI 725. Part Number: A54376, Synchron LXi 725 APF, Part Number: A54377, Synchron LXi 725 AAF. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration 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: K023049
Affected lot / code info: Part Number: A54376, Synchron LXi 725 APF, Lot Number: 722633, 823669. Part Number: A54377, Synchron LXi 725 AAF Lot Number: 722632, 823671.

Why it was recalled

The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.

Root cause (FDA determination)

Software design

Action the firm took

Beckman Coulter sent a "PRODUCT CORRECTIVE ACTION" letter dated September 24, 2008 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were instructed to complete and return the enclosed response form. Customers with questions regarding this notification were instructed to contact Technical Support at (800) 854-3633 or their local Beckman Coulter representative.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the country of Canada.

Timeline

Recall initiated: 2008-09-11
Posted by FDA: 2012-04-06
Terminated: 2012-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107334. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.