Z-1098-04

Synchron LX Clinical Systems, Operating Software, All versions

Name: Z-1098-04 Synchron LX Clinical Systems, Operating Software, All versions
Creator: Beckman Coulter Inc
Published: 2003-10-10
License: https://open.fda.gov/license/

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

FDA source

Beckman Coulter Inc began a recall of Synchron LX Clinical Systems, Operating Software, All versions on 2003-10-10. The reason FDA records is "Numeric results are erroneously accepted by the in-house information system without qualifying symbols "<" or ">". In addition, the in-house system may interpret the results incorrectly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1098-04
Status: Terminated
Initiated: 2003-10-10
Posted: 2004-07-20
Terminated: 2004-07-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Synchron LX Clinical Systems, Operating Software, All versions.
Product code: EXEMP
Reason for recall: Numeric results are erroneously accepted by the in-house information system without qualifying symbols "<" or ">". In addition, the in-house system may interpret the results incorrectly.
FDA root cause: Other
Quantity in commerce: 816
Product codes and lots: All Versions.

Product code EXEMP

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)