No sample has been returned for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.All lots are verified that all required tests have been performed and all acceptance criteria were met.No image was provided of fluid leakage from the cassette.Images of the fluidics module (inner shell) were provided by the customer which showed a white powder-like residue on the fluidics module (inner side).We could not ascertain from the images the failure mode for the consumable cassette.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.The manufacturer internal reference number is: (b)(4).
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