Z-0935-04

Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid)

Name: Z-0935-04 Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid)
Creator: Beckman Coulter Inc
Published: 2003-06-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-06-11 / Terminated

FDA source

Beckman Coulter Inc began a recall of Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid) on 2003-06-11. The reason FDA records is "Product was found to produce higher recoveries by about 7-12% compared to other lots". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0935-04
Status: Terminated
Initiated: 2003-06-11
Posted: 2004-07-20
Terminated: 2004-05-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).
Product code: KLT Enzyme Immunoassay, Carbamazepine
Reason for recall: Product was found to produce higher recoveries by about 7-12% compared to other lots.
FDA root cause: Other
Action: Users were requested to discard and ask for replacement of the lot in question by letter.
Quantity in commerce: unknown
Distribution: Nationwide and Canada
Product codes and lots: Lot M207140

Product code KLT

K955644Class IISynchron Systems Carbamazepine Test SystemBeckman Instruments, Inc. / cleared 1996-02-16

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)