The customer stated that they received erroneous results for one patient sample tested for the elecsys tsh assay (tsh), elecsys ft3 iii (ft3), and the elecsys ft4 ii assay (ft4) on a cobas 8000 e 801 module.It was asked, but it is not known if any erroneous results were reported outside of the laboratory.Please refer to the medwatches with the following patient identifiers for information related to each affected assay: (b)(6) = ft3, (b)(6) = tsh, (b)(6) = ft4.The customer initially tested the sample on their e801 analyzer on (b)(6) 2018.The sample was provided for investigation, where it was tested on a second e801 analyzer, a cobas 8000 e 602 module (e602), and a cobas e 411 immunoassay analyzer (e411) on (b)(6) 2018.The sample was also repeated on a centaur analyzer.No adverse events were alleged to have occurred with the patient.The serial number of the e801 analyzer used at the customer site was asked for, but not provided.The serial number of the e801 analyzer used for investigation was (b)(4).Ft4 reagent lot number 265662, with an expiration date of 30-nov-2018 was used on this analyzer.The serial number of the e602 analyzer used for investigation was (b)(4).Ft4 reagent lot number 288197, with an expiration date of 31-dec-2018 was used on this analyzer.The serial number of the e411 analyzer used for investigation was (b)(4).Ft4 reagent lot number 288197, with an expiration date of 31-dec-2018 was used on this analyzer.
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