The italy customer reported a case was her2, 2+ (protein overexpression) with the agilent herceptest but received a result of her2 negative with fluorescence in situ hybridization (fish).It was confirmed that agilent's controls showed no issues, but customer's internal controls gave inconsistent results.Investigation found the instrument to be fully functional and customer was following the correct procedure.A replacement reagent with a different lot number was provided which resolved this issue.Instrument is running and the customer was able to complete testing.No patient impact indicated.Diagnostics were not altered.There was no direct or indirect patient harm or user harm reported.
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