Beckman Coulter Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Beckman Coulter Inc.
Lot Codes / Batch Numbers
N/A
Products Sold
N/A
Beckman Coulter Inc. is recalling UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems The Unicel DxC Integrated Work due to The recall was initiated after Beckman Coulter confirmed reports of inaccurate Access Intrinsic Factor Ab test results displayed on, or printed from, . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026