; or (B) to remedy a violation of this Act caused by the in vitro clinical test which may present a risk to health. (2) Exception for in vitro clinical tests offered under a technology certification order For any eligible test offered under a technology certification order under section 587D, a correction and removal report for any correction or removal of an in vitro clinical test should demonstrate that the issue or issues causing the correction or removal do not adversely impact the ability of other in vitro clinical tests offered under the same technology certification order to meet the applicable standard. (c) Timing A developer shall submit any report required under this subsection to the Secretary within 15 business days of initiating such correction or removal. (d) Recordkeeping A developer of an in vitro clinical test that undertakes a correction or removal of an in vitro clinical test which is not required to be reported under this subsection shall keep a record of such correction or removal. (e) Recall communications Upon the reporting of a correction or removal by the developer— (1) the Secretary shall classify such correction or removal under this section within 45 calendar days