The investigation determined that discordant non-reactive vitros hiv combo results were obtained from a reactive vitros hiv p24 antigen qc fluid lot 0150 when using vitros immunodiagnostics products hiv combo (hivc) reagent lot 0950 in conjunction with a vitros 3600 immunodiagnostic system.A definitive assignable cause cannot be determined.The customer made no suggestion of any issues with the other qc fluids processed at the customer site and no issues regarding accuracy or precision of the vitros assay were indicated by the customer up to (b)(6) 2023.The customer did not perform any precision testing on the instrument so no assessment of the instrument performance at the time of the event was made.Additionally, the ortho tsc established that the reagent cooling had shut down on the instrument up to five (5) days before the discordant p24 qc fluid results were obtained.Therefore, it cannot be confirmed that the instrument was operating as intended and unexpected instrument performance and the condition of the vitros hiv combo reagents cannot be completely ruled out as contributing to the event.Vitros p24 qc fluid handling, transportation and storage cannot be ruled out as a contributor to the event as it was determined that the control fluid may not have been supplied in the expected condition (frozen) to the customer site.
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