Z-2685-2011

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

Name: Z-2685-2011 Beckman Coulter UniCel DxI 800 Access Immunoassay System with Unicel DXI system software version 4.3
Creator: Beckman Coulter Inc.
Published: 2010-07-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-07-06 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of Beckman Coulter UniCel DxI 800 Access Immunoassay System with Unicel DXI system software version 4.3 on 2010-07-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2685-2011
Status: Terminated
Initiated: 2010-07-06
Posted: 2011-06-28
Terminated: 2012-05-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter UniCel DxI 800 Access Immunoassay System with Unicel DXI system software version 4.3
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: 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 tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 626 units
Distribution: Nationwide in the US and to Canada
Product codes and lots: Part Numbers: A71456, 973100, A25288, A25285 with Unicel DXI system software version 4.3

Product code JJE

K023764Class IUnicel Dxi 800 Access Immunoassay System, Model 973100Beckman Coulter, Inc. / cleared 2003-01-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)