Customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.No hardware errors or other assay issues were reported in conjunction with this event by the customer.The instrument is correctly maintained by the customer.No issues with sample integrity were reported by the customer.Calibration passed on 20may2019.Qc was passing within the laboratory¿s established ranges at the time of the event.Per the progesterone instructions for use, part number: a34447 m, the range of observations for non-pregnant females in the mid-follicular phase is 0.31-1.52 ng/ml.The progesterone reagent was not returned for evaluation.The cause of this incident cannot be determined with the available information.The beckman coulter internal identifier for this event is case-(b)(4).
|