—#111456

Product

UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI 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
510(k) numbers: K023764, K042291
Affected lot / code info: Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285.

Why it was recalled

The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.

Root cause (FDA determination)

Software design

Action the firm took

The firm, Beckman Coulter, sent an "URGENT PRODUCT CORRECTION" letter dated October 13, 2011 with attached PCA Response Form to all customers who purchased the UniCel Dxl Immunoassay Systems and DxC Clinical Systems which includes all software versions. The letter describes the product, problem and actions to be taken. The customers were instructed verify the system temperatures immediately following each initialization; do not begin processing samples until this verification is complete; refer to the appendix included with the letter for detailed instructions about verifying system temperatures; review their quality control (QC) performance history; and share this information with their staff and retain this information as part of their quality system documentation, and to complete and return the enclosed response form within 10 days to Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318; Attn: Regulatory Affairs or fax to: 1-786-639-4000. Customers with any questions regarding the notice, were instructed to contact Customer Support Center via our website, http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers were instructed to contact their local Beckman Coulter Representatives.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) and countries of: Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea,Republic of; Kuwait, Liechtenstein, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.

Timeline

Recall initiated: 2011-10-13
Posted by FDA: 2012-08-23
Terminated: 2012-08-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111456. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.