Z-1378-04

SYNCHRON Clinical Systems Enzyme Validator Kit

Name: Z-1378-04 SYNCHRON Clinical Systems Enzyme Validator Kit
Creator: Beckman Coulter Inc
Published: 2004-07-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-07-29 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc began a recall of SYNCHRON Clinical Systems Enzyme Validator Kit on 2004-07-29. The reason FDA records is "incorrect Calibration Acceptance Limits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1378-04
Status: Terminated
Initiated: 2004-07-29
Posted: 2004-08-17
Terminated: 2005-02-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: SYNCHRON Clinical Systems Enzyme Validator Kit
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: incorrect Calibration Acceptance Limits.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Recall letter sent 07/29/2004, informing customers to discard all calibration diskettes and load a new calibration diskette.
Quantity in commerce: 771
Distribution: Nationwide & Canada
Product codes and lots: M310400

Product code JIX

K984014Class IISynchron Systems Enzyme Validator Set Levels 1 and 2Beckman Coulter, Inc. / cleared 1998-12-23

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)