Recall of LCx Neisseria gonorrhoeae assay and implications for laboratory testing for N. gonorrhoeae and Chlamydia trachomatis.

On July 18, 2002, Abbott Laboratories (Abbott Park, IL) initiated a voluntary recall of its LCx Neisseria gonorrhoeae Assay (List Numbers 8A48-81 and 8A48-82) because, during routine quality assurance testing, several reagent lots failed to meet the analytical sensitivity described in the product insert. The cause of the failure is under investigation by the company. Abbott Laboratories has sent a letter to its customers informing them of this recall and the specific reagent lot numbers not meeting the analytical sensitivity.