; (ii) there are reasonable grounds to believe that the in vitro clinical test was not properly developed or manufactured considering the state of the art as it existed at the time of its development; (iii) there are reasonable grounds to believe that the unreasonable risk was not caused by failure of a person other than a developer, importer, distributor, or retailer of the in vitro clinical test to exercise due care in the installation, maintenance, repair, or use of the in vitro clinical test