Z-2386-2008

Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System

Name: Z-2386-2008 Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System
Creator: Beckman Coulter Inc
Published: 2008-04-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-04-03 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc began a recall of Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System on 2008-04-03. The reason FDA records is "The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the Access and Access 2 Immunoassay Systems. Premature failure of the waste pump tubing may negatively...". 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-2386-2008
Status: Terminated
Initiated: 2008-04-03
Posted: 2008-09-21
Terminated: 2011-11-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System
Product code: CFR Hexokinase, Glucose
Reason for recall: The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the Access and Access 2 Immunoassay Systems. Premature failure of the waste pump tubing may negatively affect precision.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A Product Corrective Action (PCA) letter with attached Fax-Back Customer Response form was mailed on April 16, 2008 via US Postal mail to all affected customers with Access and Access 2 Immunoassay Systems, Synchron LXi 725 Systems and UniCel DxC 600i Systems. Customers were informed about the issue and asked to inspect for leaking or damaged tubing on all peristatic pump Mfg. No. 01-00772205 with a SN higher than 2234980. A toll free Customer Technical Support telephone was included in the letter. After further investigation by the firm, an Updated PCA letter with attached Fax-Back Customer Response form was mailed on June 30, 2008 via US Postal mail to include all customers with the following products: UniCel Dxl 800 and DxC 880i Systems with pump manufacturing number (Mfg.) of 01-010341-1 and serial number (SN) 22454201 and above, and UniCel Dxl 600 Systems with a pump Mfg. No. A24468 and SN of 22965501. Customers were informed about the issue and asked to inspect for leaking or damaged tubing on all peristatic pump SN referenced. If you have questions, contact Customer Technical Support at 1-800-854-3633.
Quantity in commerce: 694 Worldwide; 656 in US & 38 in Canada total for all products
Distribution: Nationwide, and in Canada
Product codes and lots: Unicel DxC 600i with Peristaltic Pumps with Serial Numbers above 22349820 ; Unicel Dxl 600 Peristaltic Pumps with Serial Numbers of 22965501 and above

Product code CFR

K060256Class IIUnicel Dxc 600I Synchron Access Clinical SystemBeckman Coulter, Inc. / cleared 2006-02-27

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)