FDA POSTS NOTICE OF FETALSCREEN TEST RECALL

The FDA's Center for Biologics Evaluation and Research (CBER) recently posted a recall notice for two lots of Ortho-Clinical Diagnostics' Fetalscreen test.

The recall, initiated Jan. 9 and posted to the FDA website Feb. 13, was issued because Ortho-Clinical has received reports of weak or negative reactivity with the positive control provided in the test, CBER said. The firm "has confirmed this issue and has determined that the positive control is not consistently producing the expected results described in the package insert," the agency said.

The recall notice can be viewed at www.fda.gov/cber/recalls/fetorth010907.htm (http://www.fda.gov/cber/recalls/fetorth010907.htm).