A review of manufacturing records found no discrepancies.The customer was unable to provide the exact lot number for the device.There records show three lot numbers on hand.The complaint device was used and is unable to be tested, however, reference samples retained by asc were tested from the three lot numbers provided by the customer.All samples tested met acceptance criteria.On (b)(6) 2020 unused devices were returned to asc by the customer.Samples from the returned devices were also tested.All samples tested met acceptance criteria.At this time we consider this complaint to be closed.
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