Z-0886-06

SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824

Name: Z-0886-06 SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824
Creator: Beckman Coulter Inc
Published: 2006-03-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-03-30 / Terminated

FDA source

Beckman Coulter Inc began a recall of SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824 on 2006-03-30. The reason FDA records is "Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M511327. Internal QC recovery was as much as 15% lower than the assigned...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0886-06
Status: Terminated
Initiated: 2006-03-30
Posted: 2006-05-18
Terminated: 2012-02-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.
Product code: LEH Radioimmunoassay, Vancomycin
Reason for recall: Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M511327. Internal QC recovery was as much as 15% lower than the assigned target value.
FDA root cause: Other
Action: A Product Corrective Action (PCA) letter was be sent the week of MAR 30, 2006 to all SYNCHRON Systems Vancomycin Reagent customers of lot numbers M507219 and M511327 informing them to discontinue use and discard reagent. (Letters were sent by US mail)
Quantity in commerce: 3147
Distribution: Nationwide & Canada
Product codes and lots: Lot numbers M507219 & M511327

Product code LEH

K013076Class IISynchron Systems Vancomycin Reagent; Synchron Systems Vancomycin CalibratorBeckman Coulter, Inc. / cleared 2001-12-12

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)