—#122543

Product

Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative 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
Affected lot / code info: Part Number 81901, Lot Numbers: 13181168-13341170.

Why it was recalled

Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, including the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725 Clinical System, and UniCel DxC 600i SYNCHRON Access Clinical System because Beckman Coulter has observed an intermittent increase in Access System "Wash Carousel Motion Errors" with specific lots of Access System Reaction Vessels (RVs). I

Root cause (FDA determination)

Pending

Action the firm took

Beckman Coulter sent an Urgent Product Correction (PCA) letter dated October 1, 2013, along with a customer response form to all affected customers on October 2, 2013. The customer letter informed customers of the recall with the issue, impact, action (If your Access Immunoassay System experiences Wash Carousel Motion Errors that cannot be corrected with normal troubleshooting measures as outlined in the Access 2 Reference Manual section 6.3, contact Beckman Coulter Customer Technical Support. If you do not have Access System RVs with the lot numbers listed above, or if your Access Immunoassay System is not experiencing Wash Carousel Motion Errors, no additional action is required.), resolution, and contact information, website: http://www.beckmancoulter.com. Customers in the United States and Canada with questions were instructed to call 1-800-854-3633, outside the United States and Canada, customers were instructed to contact their local Beckman Coulter representataive. For questions regarding this recall call 714-961-4941.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, JordanMalaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam.

Timeline

Recall initiated: 2013-10-02
Posted by FDA: 2013-12-16
Terminated: 2014-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122543. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.