The Recall Desk
ModerateFDA (Devices)·Z-0176-2015·Announced 2014-11-12

Beckman Coulter Recalls DxC 600i Analyzer Console PC Due to Error

Beckman Coulter is recalling the Small Form Factor Console PC for the DxC 600i analyzer because it may experience an 'MFC Exception' error during normal operation.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a software error ('MFC Exception') that may affect operation, fitting the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported or a voluntary precautionary recall.

Plain-English summary

Beckman Coulter Inc. is recalling the Small Form Factor Console PC (SFF PC), Catalog No. B23083, which is used with the UniCel DxC 600i SYNCHRON Access Clinical Analyzer. The recall involves 1,519 units distributed worldwide, including the United States and numerous other countries.

The recall is being issued because the console PC may experience an "MFC Exception" error during the normal operation of the analyzer system. This error could potentially affect the functionality of the in vitro diagnostic device used for determining analyte concentrations in human body fluids.

Healthcare facilities and users should contact Beckman Coulter for further instructions on how to address the issue. The source text does not specify a particular corrective action such as repair or replacement, nor does it report any illnesses or injuries associated with this defect.

The recalled product

Product
UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes con
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — In Vitro Diagnostic Analyzer
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial No. 504489 502713 503114 503824 504400 504373 501946 507570
  • 503285
  • 800337
  • 509705 509724 509800 509771 509744 509746
  • 508910
  • 508912
  • 508907 509373
  • 509304 506566 508920 505811 508914
  • 508917 509625 502796 508933
  • 508934 509291 509634
  • 509635 509530
  • 509588 509787
  • 509788
  • 509783 509433
  • 509437
  • 509662
  • 509663
  • 509660
  • 509659
  • 509658 509715 509657 508916

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

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Same hazard · software error

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