—#97820

Product

UniCel DxI 600 Access Immunoassay Systems; Part Number(s): DxI 600: A30260, DxI 600 with spot B A71460 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: DxI System Software versions: 2.3, 2.4, 4.1, 4.2.1, 4.3 (Current released version), 4.3.2 (Released to a single Japanese customer only)

Why it was recalled

The recall was initiated due to Beckman Coulter receiving a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation area in one push. The first rack of the two was not scanned. This is referred to as a "pushed pair." If a pushed pair event occurs, results may be associated with the incorrect patient identification.

Root cause (FDA determination)

Pending

Action the firm took

Beckman Coulter sent an Urgent: Field Safety Notice Product Correction letter dated January 26, 2011, via US Postal Service to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: 1. To prevent a pushed pair, be sure your sample racks are free of debris prior to use. Do not apply additional labels to the sample racks. Extra labels can obscure the edges of a sample rack, or obstruct the gap between two racks. Be sure sample labels do not extend beyond the edges of a sample rack; 2. If a pushed pair occurs on the UniCel DxI system, the system generates a yellow Event Log message - Clear the presentation tray and press ROUTINE button. This Event Log message is associated with a variety of common Sample Presentation Unit (SPU) errors. For that reason, you must review the Event Log details to confirm the pushed pair event has not occurred; 3. Detach the Appendix included with this notification and store it near your UniCel DxI system. Use the Appendix as a reference if you suspect a pushed pair event has occurred on your system. Beckman Coulter also requested their customers share the recall information with their laboratory staff, and retain pages 1 and 2 of this notification as part of your laboratory Quality System documentation. For questions regarding ththe recall notification, customers were instructed to contact Beckman Coulter Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support, or call 1-800-854-3633 in the United States or Canada. Outside the United States and Canada, contact their local Beckman Coulter Representative.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, 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 Vietnam.

Timeline

Recall initiated: 2011-01-26
Posted by FDA: 2011-04-11
Terminated: 2012-06-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97820. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.