The customer received questionable thyroid results for one patient who had a kidney transplant.Multiple samples from the patient were tested on the customer's cobas 6000 e 601 module, another cobas 6000 e 601 module, a siemens vista analyzer, and an abbot architect analyzer.Refer to the attachment to the medwatch for all patient data.The results were reported outside of the laboratory.There was no allegation of an adverse event.The serial numbers of the cobas 6000 e 601 modules were requested but were not provided.(b)(6).
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