Z-0583-06

UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier

Name: Z-0583-06 UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier
Creator: Beckman Coulter Inc
Published: 2006-02-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-02-06 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier on 2006-02-06. The reason FDA records is "The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances)". 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-0583-06
Status: Terminated
Initiated: 2006-02-06
Posted: 2006-03-03
Terminated: 2012-03-06
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances)
Root cause tag: software
FDA root cause: Software design
Action: A Product Corrective Action letter will be mailed the week of Feb 06 2006 to all UniCel 800 Dxl customers informing them of a rare condition on the UniCel Dxl 800 Access Immunoassay Systems. Under a specific set of circumstances, the UniCel Dxl 800 may aspirate a sample from an incorrect rack and generate a result, which is not flagged. (Letter is sent by US mail)
Quantity in commerce: 280 total (263 in US & 17 in Canada)
Distribution: Nationwide and Canada
Product codes and lots: Part Numbers: 386162 (software) 973100 (Instrument), Software Versions 2.2.1 and earlier.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)