Meridian Bioscience Inc. (NAS:VIVO) shares plummeted 9.5% in morning trade Wednesday after the Food and Drug Administration warned that lead tests made by its subsidiary, Magellan Diagnostics, may be inaccurate. The warning covers all four of the company's lead testing systems and is specific to tests done on blood drawn from a vein, the FDA said, which "may provide results that are lower than the actual level of lead in the blood." The problem may date back to 2014, according to the FDA. Children younger than six years old, currently pregnant women and nursing mothers who have received a lead test should speak to a health care professional about possibly getting retested, the Centers for Disease Control and Prevention said. Laboratories and health care personnel should not use any Magellan Diagnostic tests using blood drawn from a vein, the FDA said. Lead poisoning and its symptoms, which include weakness, brain damage and anemia, can be easily missed, and lead poisoning has the potential to harm babies and young children in particular. The FDA is "deeply concerned" about this and is "aggressively investigating" it, said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. Other individuals who are concerned about lead exposure should also speak to health care professionals about possibly getting retested, the FDA said. Though "most children likely received an accurate test result, it is important to identify those whose exposure was missed, or underestimated, so that they can receive proper care," said Patrick Breysse, director of the CDC's National Center for Environmental Health. Meridian Bioscience shares have risen 4.7% over the last three months, compared with a 0.8% rise in the S&P 500 (S&P:SPX) .
May 17, 2017, 11:02 a.m. EDT