The initial reporter stated that they received erroneous results for one patient sample tested with the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 ii assay on a cobas 8000 e 801 module.This medwatch will apply to tsh.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay and refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay.The customer initially tested the sample on their e 801 analyzer on (b)(6) 2019.The sample was repeated using the wako accuraseed method.The sample was provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2019.The sample was also repeated on an abbott architect analyzer.No adverse events were alleged to have occurred with the patient.The serial number of the customer's e 801 analyzer is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Tsh reagent lot number 365417, with an expiration date of february 2020 was used on this analyzer.
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