Z-0096-04

Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems...

Name: Z-0096-04 Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems...
Creator: Beckman Coulter Inc
Published: 2003-09-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-09-18 / Terminated

FDA source

Beckman Coulter Inc began a recall of Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems, Synchron LXi Systems on 2003-09-18. The reason FDA records is "Sample wheel may home to the wrong position". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0096-04
Status: Terminated
Initiated: 2003-09-18
Posted: 2003-11-06
Terminated: 2004-03-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems, Synchron LXi Systems.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Sample wheel may home to the wrong position.
FDA root cause: Other
Action: Recall is accomplished by telephone and by letter. Telephone calls were made by 9/24/2003. All customers have been notified by telephone.
Quantity in commerce: 154
Distribution: Nationwide and Canada
Product codes and lots: All those with version 4.0 operating software.

Product code JQP

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)