Z-0856-2010

UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access...

Name: Z-0856-2010 UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access...
Creator: Beckman Coulter Inc.
Published: 2009-10-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-10-28 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with Dxl System Software versions 4.2... on 2009-10-28. The reason FDA records is "This recall was initiated because of software issue was identified in System Software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. Instead of generating a red...". 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-0856-2010
Status: Terminated
Initiated: 2009-10-28
Posted: 2010-02-25
Terminated: 2012-05-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with Dxl System Software versions 4.2 or 4.2.1. In vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentrations found in human body fluids.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: This recall was initiated because of software issue was identified in System Software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. Instead of generating a red warning event and stopping sample processing, the system will post a yellow caution event and continue to operate with the dispense plate in an elevated position until the instrument
Root cause tag: software
FDA root cause: Software design
Action: Beckman Coulter issued an "Urgent: Product Corrective Action" letter dated October 28, 2009. Customers were notified of the affected product and how the issue will be resolved. For further information, contact Beckman Coulter Inc. Technical Support at 1-800-854-3633.
Quantity in commerce: 377 Instruments
Distribution: Worldwide Distribution -- United States and Canada.
Product codes and lots: DxI software versions: 4.2 and 4.2.1. For labeling see UniCel DxI Operator's Guide. Part Number: 387262G

Product code JJE

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)