; and (2) not later than 45 calendar days after the developer or other responsible party notifies the Secretary that it has completed a recall action, the Secretary shall provide the developer or other responsible party with a written statement closing the recall action or stating the reasons the Secretary cannot close the recall at that time. (f) Limitation The developer is not required to report a correction or removal of an in vitro clinical test based solely on an adverse event report under section 587L that captures an error within the approved performance standards for such test. (g) Definitions For purposes of this section— (1) the term correction means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of an in vitro clinical test without its physical removal from its point of use to another location, and does not include routine servicing