Calibration and qc at the investigation site were acceptable.From the information provided, a general reagent issue can be excluded.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials, and the standardization methodology used.The investigation did not identify a product problem.
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The initial reporter questioned thyroid results for 1 patient sample tested on a cobas e801 module.The sample was submitted for investigation where discrepant results were identified for elecsys ft4 iii (ft4 iii) and elecsys tsh (tsh) between the customer¿s e801 module, an e801 module used at the investigation site, and the abbott architect method.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the tsh results.No questionable results were reported outside of the laboratory.The customer¿s e801 module serial number was not provided.The e801 module used at the investigation site was 14d9-06.The ft4 iii reagent lot number used at the investigation site was 630888 with an expiration date of 31-may-2023.
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