Z-2388-2010

GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20...

Name: Z-2388-2010 GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20...
Creator: Beckman Coulter Inc.
Published: 2010-04-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-04-15 / Terminated

FDA source

Beckman Coulter Inc. began a recall of GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20 PRO, LXI 725, UniCel DxC 600, UniCel DxC 600 PRO... on 2010-04-15. The reason FDA records is "UniCel DxC and Synchron LX instruments produced inaccurate (low) GLUCm results. False low results could affect or delay diagnosis or treatment". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2388-2010
Status: Terminated
Initiated: 2010-04-15
Posted: 2010-09-09
Terminated: 2013-12-31
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20 PRO, LXI 725, UniCel DxC 600, UniCel DxC 600 PRO, UniCel DxC 600i, UniCel DxC 800, UniCel DxC 800 PRO, UniCel DxC 880i, UniCel DxC 680i, UniCel DxC 660i, and UniCel DxC860i ),
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: UniCel DxC and Synchron LX instruments produced inaccurate (low) GLUCm results. False low results could affect or delay diagnosis or treatment.
FDA root cause: Other
Action: Beckman Coulter issued an "Urgent: Product Corrective Action" (PCA) letter dated April 2010 to all consignees, identifying the reason for the recall, the affected lots, and the potential for inaccurate GLUCm results due to bubble retention and short samples. Customers were instructed to: 1) establish specific protocols for samples from defined patient populations or sample types, which could include running specimens using GLUCm in duplicate or using cartridge glucose. 2) To reduce the possibility of inaccurate results, ensure that all elements are properly installed and secured, the sample probe is adequately tightened, and proper sample volume and integrity are maintained. A copy of the PCA letter will also be included in all new instrument ship kits. Consignees were instructed to complete and return an enclosed response form. Consignees can contact Beckman Coulter at 1-973-956-5300 .
Quantity in commerce: 84,186 units (79,071 in US & 5,115 in Canada)
Distribution: Worldwide Distribution: USA and Canada
Product codes and lots: All non-expired lots are affected by the recall.

Product code CGA

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)