PSA testing is considered controversial. The United States Preventive Services Task Force, the group that sets testing guidelines, recommends against PSA testing. But the American Cancer Society, the American Urological Organization and the American College of Physicians suggest offering the test to patients based on a variety of factors, including age and family history of prostate cancer.
Siemens had another PSA test recall in 2012, when leaking cartridges were thought to "depress" positive test results, according to FDA enforcement actions. They recalled about 1,100 cartridges.
A two-month FDA inspection of Siemens' facility in Tarrytown, N.Y., in 2011 yielded several violations, including failure to review and evaluate complaints to see whether an investigation was necessary. On July 17, 2013, the FDA wrote that all issues had been resolved.