The investigation determined that higher and lower than expected quality control results were obtained from vitros free thyroid control lot 460 processed using vitros tsh reagent lot 6395 and vitros ft4 reagent lot 4600 in combination with a vitros xt7600 integrated system.The definitive assignable cause of the event was not determined.Ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with this vitros tsh lot 6395 and ft4 lot 4600.Pre-analytical sample mixup cannot be ruled out as a potential contributor to the event as the level 1 & 3 results obtained for both tsh and ft4 are similar in concentration to the ftc level 2 package insert means.However, the customer declined this conclusion indicating that they tried fresh qc and the results were still unacceptable until they ran the qc on alternate tsh and ft4 reagent lots.The customer reported that due to this issue they discarded all ftc level 2 vials which could infer the wrong qc level was processed, but this could not be confirmed.A review of historical quality control results for both tsh lot 6395 and ft4 lot 4600 indicate acceptable performance up until 29 april 2021 when they reported the unacceptable ftc results.There was no indication that the vitros xt7600 integrated system malfunctioned.Within run precision testing was conducted around the time of the event to verify instrument performance and acceptable results were obtained confirming an instrument issue was not a likely contributor to the event.Email address for contact office is (b)(4).
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