; or (B) an injury that— (i) is life threatening; (ii) results in permanent impairment of a body function or permanent damage to a body structure; or (iii) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. 587M. Corrections and removals (a) In general The Secretary shall promulgate regulations to implement this section, including information necessary to be reported to ensure the analytical and clinical validity of in vitro clinical tests, and the safety of specimen receptacles. (b) Reports of removals and corrections (1) In general Each in vitro clinical test developer or importer shall report to the Secretary any correction or removal of an in vitro clinical test undertaken by such developer or importer if the removal or correction was undertaken— (A) to reduce the risk to health posed by the in vitro clinical test; 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 No report of the correction or removal of an in vitro clinical test is required under paragraph (1) if a report of the correction or removal is required under, and has been submitted under, section 587L. (c) Timing A developer or importer 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 or importer of an in vitro clinical test who 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 voluntary reporting of a correction or removal by the developer— (1) the Secretary shall classify such correction or removal under this section within 15 calendar days