Z-1151-04

Synchron Liquid Comprehensive Chemistry Control Serum. Part numbers: 660710, 657365

Name: Z-1151-04 Synchron Liquid Comprehensive Chemistry Control Serum. Part numbers: 660710, 657365
Creator: Beckman Coulter Inc
Published: 2003-04-01
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-04-01 / Terminated

FDA source

Beckman Coulter Inc began a recall of Synchron Liquid Comprehensive Chemistry Control Serum. Part numbers: 660710, 657365 on 2003-04-01. The reason FDA records is "The quality control samples for Vancomycin would not recover correctly when compared to the S.I. unit values listed in the incorrectly printed product insert. The incorrectly printed values were higher than they should...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1151-04
Status: Terminated
Initiated: 2003-04-01
Posted: 2004-07-23
Terminated: 2004-08-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Synchron Liquid Comprehensive Chemistry Control Serum. Part numbers: 660710, 657365.
Product code: LEH Radioimmunoassay, Vancomycin
Reason for recall: The quality control samples for Vancomycin would not recover correctly when compared to the S.I. unit values listed in the incorrectly printed product insert. The incorrectly printed values were higher than they should be by a factor of 3 (three).
FDA root cause: Other
Quantity in commerce: 9730
Product codes and lots: Lots: M202040, M206290

Product code LEH

K013235Class IModification to Synchron ControlBeckman Coulter, Inc. / cleared 2001-10-16

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)