There may be wear of the ratio pump, build-up on the chloride electrode silver iodide and microbial contamination, apparently based on a maintenance-related issue, the FDA said. The company sent customers a Product Corrective Action letter about the issue on April 5.
The action is an FDA Class 1 recall, the most serious type, involving a reasonable probability that use of the product will cause serious adverse health consequences or death.
Read the FDA release on the Beckman Coulter recall.
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