Additional information was added: two (2) actual devices were received for evaluation.Visual inspection was performed using the naked eye which observed that the ink of the labels was removed and parts are illegible.The reported condition was verified.This ink is water base, therefore, contact with liquid that always used for wiping down the products, occasioned this failure mode.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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