; and (B) an accurate statement of the quantity of contents in terms of weight, measure, or numerical count, unless an exemption is granted by the Secretary by the issuance of guidance, such as with respect to small packages. (3) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling, including a test report, is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (4) Unless its labeling bears adequate directions for use and such adequate warnings as are necessary for the protection of users of the in vitro clinical test and recipients of the results of such in vitro clinical test, including patients, consumers, donors, and related health care professionals. Required labeling for in vitro clinical tests intended for use in health care facilities, blood establishments, or by a health care professional may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of law, and that the test developer, or distributor affords such users the opportunity to request the labeling in paper form, and after such request, promptly provides the requested information without additional cost. (5) If there is a reasonable probability that it could cause serious or adverse health consequences or death, including through absence, delay, or discontinuation in diagnosis or treatment, when used in the manner prescribed, recommended, or suggested in the labeling thereof. (6) If it was developed, sterilized, packaged, repackaged, relabeled, installed, or imported in an establishment not duly registered under section 587J or it was not included in a listing under section 587J, in accordance with timely reporting requirements under this subchapter. (7) In the case of any in vitro clinical test