The customer initially complained of discrepant results between elecsys ft4 ii assay (ft4 ii) and elecsys ft4 iii (ft4 iii) for 2 patient samples tested on a cobas 6000 e 601 module.The customer reported the results outside of the laboratory and requested for the samples to be investigated.The samples were submitted for investigation where discrepant results were identified for ft4 ii, ft4 iii, elecsys ft3 iii (ft3 iii) and elecsys tsh assay (tsh) between the customer's e601 module, the centaur method, a cobas e801 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.Patient identifiers: (b)(6).Refer to attached data for the patient results.There was no allegation that an adverse event occurred.The customer's e601 module serial number was (b)(4).The e801 module serial number was (b)(4).The e411 analyzer serial number was (b)(4).The ft4 ii reagent lot number used at the investigation site was 288197 with an expiration date of dec-2018.
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