The investigation determined that a lower than expected vitros b-hcg ii result was obtained when vitros reproductive endocrine quality control fluids were tested using vitros b-hcg ii lot 3790 on a vitros eci immunodiagnostic system.The most likely assignable cause of the event is microwell incubator contamination.The customer stated that their analyzer was located near the bathrooms in their facility, and that they clean using chlorine bleach.Per the vitros eci instructions for use: soapy water is used for general cleaning; however, a 2% solution of fl-70 in water may be used in place of soapy water.Do not use sodium hypochlorite, bleach, ammonia, or any ammonia-containing compound, or any other oxidizing agents to clean any system components.Such use may result in erroneous results and may also corrode metal parts.Although the customer was not cleaning the analyzer directly with bleach, it is possible for the fumes to lead to erroneous results on the system.The customer relocated the analyzer away from the bathroom and performed the microwell incubator decontamination procedure, after which the vitros b-hcg results returned to expectation.Historical vitros b-hcg ii lot 3790 results from biorad qcs indicated acceptable reagent performance, therefore ruling out an issue with the reagent lot.Additionally, continual tracking and trending does not indicate a systemic issue with vitros b-hcg reagent lot 3790.
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