The customer received questionable thyroid results for one patient from cobas 8000 e 602 module serial number (b)(4).The results were reported outside of the laboratory and the physician asked for the confirmation of the results.The sample was submitted for investigation and was tested on a cobas 8000 e 602 module, a cobas e 411 immunoassay analyzer, and a centaur analyzer.Refer to the attachment to the medwatch for all patient data.There was no allegation of an adverse event.Medwatchs for this event include those with a1.Patient identifier = (b)(6).
|