Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its Access Sensitive Estradiol [Reference: B84493; All Lots].
The manufacturer has identified the potential for bi-directional interference with the Access Sensitive Estradiol assay in samples containing elevated levels of Estrone and Estrone-3-Sulfate. Bi-directional interference can be a positive or negative bias, depending upon the analyte and interferent concentrations present in the sample. Estradiol supplements may elevate estrone and estrone-3-sulfate concentrations to levels that are higher than those observed under typical clinical conditions.
According to the manufacturer, the Access Sensitive Estradiol test results may be either falsely increased or falsely decreased if they are measured after a patient receives estradiol supplements. The magnitude of a falsely increased or decreased Estradiol test result depends upon the concentrations of estrone, estrone-3-sulfate and estradiol that are present in the sample. Access Sensitive Estradiol results obtained from adults and adolescents with typical Estrone and Estrone-3-Sulfate levels are not impacted.
The manufacturer is instructing affected users not to use the Access Sensitive Estradiol assay to monitor the effectiveness of estradiol supplements. The manufacturer is also advising affected users to consider the patient's total clinical presentation when interpreting results. Affected users should use alternative testing methods if the results are not consistent with accompanying clinical evidence. Any retrospective review of patient results is left to the discretion of the Laboratory Medical Director.
The manufacturer will update the Access Sensitive Estradiol Instructions for Use (IFU) Limitations section.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 13 April 2021