If air bubbles are present, accuracy of the ISE test results may be affected.Ī customer notification letter dated 9/9/13 was sent to customers who received the ISE REF Valve, Part Number MU3226 for the AU400, AU640, AU2700, AU5400 and the ISE REF Valve, Part Number MU7638 for the AU480, AU680, AU5800 Chemistry Analyzers. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Class 2 Device Recall Beckman Coulter AU480, AU680, AU5800, and AU5400 Clinical AnalyzersĪnalyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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