Johnson & Johnson Recalls Chemical That Could Give Faulty Test Results

On Friday, Ortho-Clinical Diagnostics Inc., a Johnson & Johnson company, announced the recall of a chemical that could produce false negatives when used in HIV, hepatitis, pregnancy, and other diagnostic tests. The problem with the reagent used in the Vitros Immunodiagnostic ECi/ECiQ laboratory test system was discovered during quality testing and not during testing on patients, said company spokesperson Stephen Dnistrian.

The voluntary recall affects two of 50 lots of Vitros Signal Reagent, lots 8350 and 8530, catalog No. 107 2693, said Dnistrian. Ortho-Clinical has not received any reports of injuries associated with the reagent used in the test system, he said, adding that the company has confirmed that three U.S. and five overseas labs received the faulty lots.

The test system is used to screen for more than 40 diseases and conditions, including thyroid disorders and heart attacks. The company is recommending that any patients who underwent diagnostic testing for any of these medical conditions in the past 60 days and are concerned about their results discuss the matter with their doctors. Laboratories with questions should telephone Ortho-Clinical at 800-421-3311. More information is available at www.orthoclinical.com.

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