Z-1148-04

Synchron Systems Prealbumin Reagent Part Number: 475106

Name: Z-1148-04 Synchron Systems Prealbumin Reagent Part Number: 475106
Creator: Beckman Coulter Inc
Published: 2003-05-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-05-20 / Terminated

FDA source

Beckman Coulter Inc began a recall of Synchron Systems Prealbumin Reagent Part Number: 475106 on 2003-05-20. The reason FDA records is "Instability leading to falsely elevated patient results, out of range controls, or error code". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1148-04
Status: Terminated
Initiated: 2003-05-20
Posted: 2004-07-23
Terminated: 2004-08-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Synchron Systems Prealbumin Reagent Part Number: 475106
Product code: JIS Calibrator, Primary
Reason for recall: Instability leading to falsely elevated patient results, out of range controls, or error code.
FDA root cause: Other
Quantity in commerce: 1631 kits
Product codes and lots: Lot M210125 Exp 30 Nov 04

Product code JIS

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)