(b)(6) 2021 customer reporting no call int ctl on qc and patient samples while utilizing the verigene bc-gn assay.Ts requested data and sent a return label to the customer and will send another blue usb to the customer as well.Per so 280785 the customer ordered 4 kits of verigene bc-gn assay with et lot 101321021b.Ts switched risk analysis question 2, "did the device malfunction, fail to meet any labeled claim, or otherwise fail to perform as described in its intended use?" to a yes.12.21.21 ts requested approval to send the customer 4 kits of the verigene bc-gn assay.12.22.21 ts received approval to send the customer 4 verigene bc-gn kits to the customer due to the no call int ctl (see email).Ts placed the order to send these kits to the customer.12.29.21 per fedex tracking (b)(4), shipment arrived at customer site and packages were signed for by (b)(6).Customer confirmed receipt and noted 2 boxes were missing from shipment.01.03.22 customer reported that the remaining boxes arrived 12.30.31 with no issues.
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