Customer reported a possible discrepancy as a sample typed fya- and upon retest, the same sample resulted in fya+.Update 01aug2023: the nature of the health hazard is considered medium since multiple false-negative results have been confirmed.The risk could be mitigated if the customer is aware of the discrepant results and can rerun the samples on another carrier.In addition, these flipped calls occurred on donor samples, and there is no risk to the donor.Any recipient would be typed and cross-matched to the donor.
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Multiple false negative calls on fya.Possible discrepancy as a sample typed fya- and upon retest, the same sample resulted in fya+.Update as of 01aug2023: trending analysis determined this is the only complaint for this lot 22-117-v of this complaint nature, however the second instance of the customer reporting false fya(0) results within the past year.The false fya(0) results are caused by the significant change in the fya/fyb delta values for samples that should result as fya(+) and is due to the reduced reactivity of the fya beads relative to the fyb beads of the beadchips.The underlying root cause of the reduced reactivity is unknown at this time.
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