The investigation determined that higher than expected anti-hbs (ahbs) results were obtained when testing a non-vitros (biorad) negative quality control (qc) fluid using a vitros ahbs reagent on a vitros xt 7600 immunodiagnostic system.A definitive assignable cause of the events was not determined with the information provided.There is no indication of an instrument malfunction; however, the customer did not perform a within run precision testing at the time of the events to definitively rule out an instrument issue.In addition, the customer is not following the manufacturer¿s recommended sample handling protocol; therefore, pre-analytical sample processing cannot be ruled out as a contributing factor.It is possible that the qc samples were not at room temperature when the samples were processed, although this could not be confirmed.The complaint review did not indicate a quality performance issue with vitros ahbs reagent lot 8931.However, it is possible that the higher than expected vitros ahbs results was due to the biorad viroclear lot 106550 qc fluid, although this could not be confirmed.Biorad has opened an investigation of biorad viroclear lot 106550, however, no conclusion has been reached at this time.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ahbs.
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