Cell Marque was hit with a Form 483 for not adequately establishing procedures for device acceptance and for reviewing complaints.
After visiting Cell Marque’s Rocklin, Calif., facility in late September and early October, inspectors reported that the company had not defined acceptance criteria for its S1OOA1 in vitro diagnostic device to ensure that it performed as intended.
S1OOA1 is an antibody used to help identify renal neoplasms. Cell Marque initiated a Class II recall of several lots of S1OOA1 in May 2016 because of lots showing no staining, which indicated potential false negative results. — Jeff Kinney