J&J Ortho user notification
This article was originally published in The Gray Sheet
Executive Summary
Ortho-Clinical Diagnostics is changing the instructions for its Ortho antibody to HBsAg ELISA System 3 confirmatory test, following several reports of false repeat reactive results confirmed with the test. The new instructions for "calculation of percent reduction results" and "specimen dilution/repeat testing and interpretation" are detailed in a 1User Notification Letter posted on FDA's website...