The medical device company Beckman Coulter, Inc., issued a recall in May for their Synchron LX Ion Selective Electrolyte Flow Cell, which is classified by the FDA as a Class I recall by the U.S. Food and Drug Administration, say reports.
Reports say the pump may wear incorrectly, causing silver iodide build-up and microbial contamination and, ultimately, incorrect electrolyte delivery, which can eventually cause adverse health consequences.
The components are are chemical analyzers that are computer-controlled which analyze blood, urine and spinal fluids samples collected from an individual.
According to reports, the FDA believes the provides incorrect Electrolyte Results. The FDA also believes the problem may be with a maintenance-related issue, but the actual cause is still being identified.
Reports say healthcare professionals are encouraged to report adverse side effects or product quality problems to the FDA's MedWatch Safety Information and Adverse Event Reporting Program to www.fda.gov/MedWatch/report.htm.
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