Abbott suspends distribution of HIV I/II assay in overseas markets due to false negatives.
This article was originally published in The Gray Sheet
Executive Summary
ABBOTT SUSPENDS DISTRIBUTION OF IMx HIV-I/HIV-II 3RD GENERATION PLUS HIV assay sold in Europe, Australia, South Africa, Latin America and Asia. Germany-based Abbott Diagnostika GmbH stopped distributing the 3rd Generation Plus test on March 25 after learning that the assay had failed to detect four confirmed positive samples in Europe. The test is not sold in the U.S., Canada or Japan.