Additional manufacturing narrative: other, other text: the returned device was evaluated.The thermometer passed visual inspection, successfully powered on, and was able to obtain measurements.During water bath temperature testing, the device provided measurements outside of tolerance.Contaminant was observed on the ir sensor lens.Cleaned external surface of the ir sensor lens, and device accuracy was retested and the temperature measurements are outside specification.A service history record review reveals that this unit was in the field for over six (6) months with no previous reported issues related to this reported event., corrected data: d4 serial # from (b)(6) to (b)(6).D4 udi# from blank field to (b)(4).H4 device manufacture date from blank field to "09/01/2020".
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