The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-12-21.H.6.Investigation summary: the customer complained about labels on 8 centrifuge tubes from an unknown lot of catalog number 491453 (totalys multiprocessor consumables kit) not containing print.Material 500024399 is a purchased subcomponent that is used in catalog 491453.The customer communicated that the lot number of defective tubes from 500024399 was supplier lot number 20u1321.A device history record review of 491453 could not be performed because a lot number was not provided.However, material 500024399 is a purchased subcomponent that is used in catalog 491453.The centrifuge tubes are polypropylene plastic injection molded parts purchased from an approved bd supplier.The supplier applies a 2-dimensional barcode on the tubes that is used to support automated chain of custody for the specimen.When received into the bd mebane, nc facility they are subjected to incoming qc inspection using an ansi, single sampling, level i, at an aql of 1.0%.A review of the inspection documentation identified that 500024399 lot 20u1321 was received and inspected on two occasions without any issues identified.Additionally, a review of the c of a provided by the supplier identified that each tube provided contained a 2d label with a unique barcode number, and confirmation that each barcode scanned a grade of either 'a' or 'b'.A retain analysis could not be conducted because retain samples of this product are not kept by bd.Three photographs were provided.The first one shows 8 tubes that have no print on the label applied to them.The 2nd picture is a close-up on 4 of the tube labels.The 3rd picture is a picture of the bag label and lot number that the tubes were identified in.Additionally, the 8 tubes and bag label were returned to the mebane, nc location for evaluation.The complaint is confirmed.H3 other text : see h.10.
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