The initial mdr 1219913-2021-00487 was filed on november 19, 2021.Additional information - december 14, 2021: an outside the united states (ous) customer reported high results for afp, needed clarification as to why on one method the neat result reported greater linearity and one method reported on curve.In further review of this case, it is likely a hook sample that hooked back into the curve due to the high amount of afp antigen present.As per the interpretation of results section in the atellica im afp instructions for use 10995310_en rev.03, 2020-02, "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." furthermore, as per the interpretation of results section instructions for use: "high afp concentrations can cause a paradoxical decrease in the rlus (high dose hook effect).In this assay, patient samples with afp concentrations above the measuring interval and as high as 1,000,000 ng/ml (830,000 iu/ml) will report >1,000.0 ng/ml (830.00 iu/ml).Results were established using the atellica im analyzer" there is insufficient sample to be sent in.The immulite and atellica im afp assays have no claim for correlation however, they do both have the same intended use.In house data was reviewed for atellica afp kit lot 238 and all release criteria was met.There has been no further request for technical assistance.No product nonconformance identified.In section h6, investigation findings, and investigation conclusion codes were updated based on the investigation results.Mdr 1219913-2021-00486 supplemental 1, mdr 1219913-2021- 00488 supplemental 1 and mdr 1219913-2021-00491 supplemental 1 were filed for the same patient.
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