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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- Manufacturer
- Beckman Coulter Inc.
- 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.
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