H.6.Investigation summary: the customer complained about an unknown lot of material 491454 having a conflicting expiration date from the subcomponents.Specifically, the customer stated that the expiration date on the outside of the box was further out than the expiration dates on the inside.However, the customer did not provide the lot number or expiration date reported on the outside of the kit, nor the expiration date(s) from the inside of the kit.A photo was not provided, nor was a sample returned by the customer.Therefore, the complaint is not confirmed.Material 491454 is produced at the bd mebane, nc facility by way of a manual pack out process in the kitting cell.No dhr review or retain analysis could be performed because no kit or subcomponent lot number was provided by the customer.The expiration date of the material 491454 is determined by subcomponent 700013131, precoat slides.Multiple lot numbers of 700013131 with different expiration dates can be used in a single production order of 491454, with the expiration date assigned to the kit being the expiration dates from the lots of 700013131 that expires the earliest.Therefore, a customer should not receive a kit that containing subcomponents with an expiration date earlier than what is labeled on the outside of the kit.A twelve-month complaint review for expiration dating issues was performed and identified no other complaints for kits containing an expiration date longer than the expiration date of the subcomponents.
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