FDA 483 - Abbott Diagnostics Scarborough, Inc. - March 02, 2018

Alere Scarborough, Inc. in Scarborough, ME, was cited for significant deficiencies in its Medical Device Reporting (MDR) processes during an FDA inspection. The firm failed to submit timely MDRs for false positive and false negative results from its Alere Determine HIV-1/2 Ag/Ab Combo assay, which could cause or contribute to serious injury or death. Additionally, the company's written MDR procedure was found to be inadequate for identifying and evaluating reportable events.