FDA Issues Class 1 Recall Of Beckman Blood Analyzer

Law360, New York (May 25, 2011, 1:42 PM EDT) -- The U.S. Food and Drug Administration announced a Class 1 recall Monday of certain Beckman Coulter Inc. computer-controlled clinical chemistry blood analyzers due to the risk that the devices may provide incorrect electrolyte results.

The Class 1 recall, the agency's most serious type, covers Beckman Coulter's Synchron LX Clinical Systems Ion Selective Electrolyte Flow Cell, which are used to determine types of chemistries from samples of blood and other fluids such as urine and cerebrospinal fluid.

Brea, Calif.-based Beckman Coulter sent its customers a product corrective...
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