The Food and Drug Administration (FDA) is recalling potentially defective laboratory instruments used to measure electrolytes in body fluids because the instruments have been giving incorrect results. The recall is listed as a Class 1, which is the most serious type of recall the agency can issue and involves situations in which there is a reasonable probability that use of the products will cause serious adverse health consequences or death.

The recalled products include models of Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Elecrolyte (ISE) Flow Cell. These are computer-controlled clinical chemistry analyzers used to determine different types of blood chemistries and other chemistries from blood samples collected from an individual. Analyses are performed on a variety of fluids including blood, urine, and cerebrospinal fluid.

The recall was initiated because there may be ratio pump wear, silver iodide build-up on the chloride electrode, microbial contamination, general non-ISE hardware, and maintenance in the instruments (ion selective electrolyte flow cell) which may cause incorrect electrolye results.

Electrolytes are tiny chemicals that help cells function properly. Electrolytes such as sodium and potassium, and others are critical in allowing cells to generate energy, maintain the stability of their walls, and to function in general. A proper balance of electrolytes is essential for muscle coordination, heart function, fluid absorption and excretion, nerve function, and concentration. Electrolytes can be knocked off balance by poor diet, dehydration, medication and disease.

The manufacturer of the instruments believes the problem to be a maintenance-related issue, though the root cause has not been definitively determined. Customers have been asked to follow maintenance instructions and report any issues with the instruments.

Source: FDA