Z-2771-2011

UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems The Unicel DxC Integrated Workstation...

Name: Z-2771-2011 UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems The Unicel DxC Integrated Workstation...
Creator: Beckman Coulter Inc.
Published: 2009-05-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-05-07 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems The Unicel DxC Integrated Workstation takes samples loaded from a single point of entry... on 2009-05-07. The reason FDA records is "The recall was initiated after Beckman Coulter confirmed reports of inaccurate Access Intrinsic Factor Ab test results displayed on, or printed from, the UniCel Dxl portion of an integrated workstation listed above. The...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2771-2011
Status: Terminated
Initiated: 2009-05-07
Posted: 2011-07-11
Terminated: 2012-05-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems The Unicel DxC Integrated Workstation takes samples loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the Dxl analyzers according to the programming requirements
Product code: LIG Radioassay, Intrinsic Factor Blocking Antibody
Reason for recall: The recall was initiated after Beckman Coulter confirmed reports of inaccurate Access Intrinsic Factor Ab test results displayed on, or printed from, the UniCel Dxl portion of an integrated workstation listed above. The problem is limited to numerical Intrinsic Factor Ab results produced on integrated systems running UniCel Dxl system software version 4.0, 4.1, or 4.2. The DxC portion of your inte
Root cause tag: software
FDA root cause: Software design
Action: Beckman Coulter, Inc. sent out an "Urgent: Product Corrective Action" letter dated May 19, 2009 to all affected customers. The letter explained the reason for recall and provided recommendations including: -System software currently under development will correct this problem, and will be made available soon. Until then, please refer to UniCel DxC reports, user interface information, and LIS transmissions, which contain accurate Access Intrinsic Factor Ab test results. -Refer to the UniCel DxC system documentation for information on displaying and printing results from the DxC portion of an integrated workstation, or from your laboratory information system (LIS) -Past results for these assays only need to be reviewed if they were reported from the Dxl portion of an integrated workstation -Complete and return the enclosed response form For additional information please contact the Customer Technical Support at 1-800-854-3633, or your local Beckman Coulter representative.
Quantity in commerce: 5 units
Distribution: Worldwide Distribution: (USA) Nationwide including KY; and the country of Canada.
Product codes and lots: N/A

Product code LIG

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)