The customer reported the traverse on the act 5 diff cp hematology analyzer was not reaching home.High unflagged platelet (plt) values and plt vote outs were also recovered for patient samples.Erroneous results generated from the analyzer, however, erroneous results reported out of the lab.There was no report of death, injury, or change to patient treatment as a result of this event.Instrument data of three (3) patient samples were provided for review.On (b)(6) 2021, patient 1 sample was run in cbc mode on the act 5 diff cp recovering high plt results of 724 x 103 cells/l with no plt specific instrument suspect messages.The patient¿s sample was rerun (x3) on the same day recovering lower plt results of 192, 123 and 105 x 103 cells/l respectively.The customer performed shutdown, startup and qc which recovered within the expected range.The patient¿s sample was reran recovering a plt result of 105 x 103 cells/l which was considered correct.On (b)(6) 2021, patient 2 and patient 3 samples were run on the act 5 diff cp instrument recovering results with plt vote outs, diff ¿r¿ flags, plt interpretation not possible, nrbc and plt aggregates instrument interpretive messages.
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