Z-1116-04

Synchron LX Clinical Systems Software

Name: Z-1116-04 Synchron LX Clinical Systems Software
Creator: Beckman Coulter Inc
Published: 2003-10-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-10-07 / Terminated

FDA source

Beckman Coulter Inc began a recall of Synchron LX Clinical Systems Software on 2003-10-07. The reason FDA records is "'Initial Rate High' parameter for User Defined Reagents does not perform as indicated in the Synchron LX Clinical Systems Operations Manual". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1116-04
Status: Terminated
Initiated: 2003-10-07
Posted: 2004-07-20
Terminated: 2004-08-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Synchron LX Clinical Systems Software
Reason for recall: 'Initial Rate High' parameter for User Defined Reagents does not perform as indicated in the Synchron LX Clinical Systems Operations Manual.
FDA root cause: Other
Product codes and lots: All Software versions.

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)