Z-0009-06

Synchron LX Systems Version 4.5 Operating Software

Name: Z-0009-06 Synchron LX Systems Version 4.5 Operating Software
Creator: Beckman Coulter Inc
Published: 2005-09-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-09-06 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of Synchron LX Systems Version 4.5 Operating Software on 2005-09-06. The reason FDA records is "Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour...". 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-0009-06
Status: Terminated
Initiated: 2005-09-06
Posted: 2005-10-06
Terminated: 2012-01-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Synchron LX Systems Version 4.5 Operating Software
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine sample, results may be reduced from above the upper limit of the laboratory's reference interval to below the limit.
Root cause tag: software
FDA root cause: Software design
Action: Customers were notified by letter dated September 6, 2005 with work around instruction provided in the letter.
Quantity in commerce: 868
Distribution: Nationwide and Canada
Product codes and lots: Synchron LX 20 and PRO Version 4.5 Operating Software Part Number A21127 (Upgrade Kit) Software Versions V4.5N4.6 CDB (Chemistry Database). Synchron LXi Version 4.5 Operating Software A21128 (Upgrade Kit) Software Versions V4.5N4.6 CDB(Chemistry Database).

Product code JJE

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)