Z-0904-04

UniCel Dxl 800 Access Immunoassay System, P/N 973100

Name: Z-0904-04 UniCel Dxl 800 Access Immunoassay System, P/N 973100
Creator: Beckman Coulter Inc
Published: 2004-03-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-03-29 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of UniCel Dxl 800 Access Immunoassay System, P/N 973100 on 2004-03-29. The reason FDA records is "Software coding error may cause a fatal error message". 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-0904-04
Status: Terminated
Initiated: 2004-03-29
Posted: 2004-07-20
Terminated: 2004-09-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel Dxl 800 Access Immunoassay System, P/N 973100.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Software coding error may cause a fatal error message.
Root cause tag: software
FDA root cause: Other
Action: Each user will be contacted initially and then once more to ensure that the users have recieved the recall letter and have installed the new software included with the letter. Recall letters were sent March 29, 2003.
Quantity in commerce: 73
Distribution: Nationwide and Canada
Product codes and lots: All software versions pior to version 1.4

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)