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U.S. Department of Health and Human Services

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Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall

Audience: Hospital risk managers, laboratory managers

[Posted 03/11/2010] FDA notified healthcare professionals of the Class I recall of UniCel DxC Synchron Clinical System – Ion Selective Electrode (ISE) Flow Cell. These systems are computer-controlled clinical chemistry analyzers used to determine different types of blood chemistries and other chemistries from blood samples collected from an individual. There may be excessive build-up of protein, bacteria, and sample tube additives in the instrument’s ion selective electrode flow cell which may cause incorrect sodium results. This product has been manufactured and distributed since November 2004. See Recall Notice for serial numbers affected by this recall.

[03/10/2010 - Recall Notice - FDA]