Z-1077-03

Synchron LX Systems Primary Tube Sample Template (a piece of ''labeling'' for use with the Synchron LX 20 and...

Name: Z-1077-03 Synchron LX Systems Primary Tube Sample Template (a piece of ''labeling'' for use with the Synchron LX 20 and...
Creator: Beckman Coulter Inc
Published: 2003-06-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-06-19 / Terminated

FDA source

Beckman Coulter Inc began a recall of Synchron LX Systems Primary Tube Sample Template (a piece of ''labeling'' for use with the Synchron LX 20 and LX 20 Pro systems). Part Number: 967178 on 2003-06-19. The reason FDA records is "Dead volume on sight gauge for the Synchron LX 20 and LX 20 Pro Systems not stated, which may result in instrument error". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1077-03
Status: Terminated
Initiated: 2003-06-19
Posted: 2003-08-06
Terminated: 2004-12-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Synchron LX Systems Primary Tube Sample Template (a piece of ''labeling'' for use with the Synchron LX 20 and LX 20 Pro systems). Part Number: 967178
Reason for recall: Dead volume on sight gauge for the Synchron LX 20 and LX 20 Pro Systems not stated, which may result in instrument error.
FDA root cause: Other
Action: A revised template with a recall letter was sent to customers with a response request on 19 June 2003.
Quantity in commerce: 502
Distribution: USA and Canada.
Product codes and lots: No range of serial numbers apply.

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)