The customer stated that they received erroneous results for two patient samples tested for elecsys ft3 iii (ft3) and elecsys ft4 ii assay (ft4) on a cobas 8000 e 602 module (e602).It was asked, but it is not known if the erroneous results were reported outside of the laboratory.This medwatch concerns the ft4 assay.Please refer to the medwatch with (b)(6) for information related to the ft3 assay.The samples were initially tested on the customer's e602 analyzer.The samples were then provided for investigation, where they were tested on a cobas 8000 e 801 module (e801), a second e602 analyzer, and a cobas e 411 immunoassay analyzer (e411).No adverse events were alleged to have occurred with the patients.The serial number of the customer's e602 analyzer was asked for, but not provided.The e801 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 215455, with an expiration date of 31-mar-2018.The e602 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 265631, with an expiration date of 31-sep-2018.The e411 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 265631, with an expiration date of 31-sep-2018.
|