—#93643

Product

Beckman Coulter UniCel DxI 800 Access Immunoassay System with Unicel DXI system software version 4.3

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K023764
Affected lot / code info: Part Numbers: A71456, 973100, A25288, A25285 with Unicel DXI system software version 4.3

Why it was recalled

Test results may have incorrect ranges. If a default sample type setting on the tests screen is changed while running Unicel DXI system software version 4.3, the new setting is not saved to the system database. The changed sample type setting will reset to the previously saved setting when power is interrupted to the system, or if an operator reboots the system. If the default sample type i

Root cause (FDA determination)

Software design

Action the firm took

Beckman Coulter forwarded on 7/6/10 a Product Corrective Action letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the UniCel Dxl 600 and Dxl 800 Access Immunoassay systems. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to: A revised version of UniCel DxI System Software that corrects this issue is currently in development. Until the new software version is available, Beckman Coulter has provided an alternate method for changing the default sample type setting. See the appendix included with this letter for additional information. Refer to the attached Questions and Answers document for additional details and instructions, and to determine if their laboratory is running UniCel DxI Sytem Software version 4.3. Customers may wish to confirm that proper ranges and units of measure are being reported for any Access assays with sample type settings that were changed while running software version 4.3. Customers were asked to share this information with their laboratory staff, and retain the notification as part of their laboratory Quality Ststem documentation. Complete and return the enclosed response form within 10 days so Beckman Coulter can be assured that consignees received the notification. If they need assistance or have any questions regarding this notification, customers were told to contact Technical Support at 1-800-854-3633 in the United States or Canada. Outside the United States and Canada, contact your local Beckman Coulter Representative.

Recalling firm

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

Distribution

Distribution pattern: Nationwide in the US and to Canada

Timeline

Recall initiated: 2010-07-06
Posted by FDA: 2011-06-28
Terminated: 2012-05-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93643. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.