& Recalls Chemical that Could Give Faulty Test Results

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CDC 04/03/06

GLOBAL: " & Recalls Chemical that Could Give Faulty Test

Results "

Associated Press (04.01.06)

On Friday, Ortho-Clinical Diagnostics Inc., a & 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 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 US

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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