Diagnostics, a Johnson & Johnson company, has recalled
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 spokesman Stephen Dnistrian.
recall affects two of 50 lots of Vitros Signal Reagent,
lots 8350 and 8530, catalog number 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
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 should discuss the matter
with their doctors if they are concerned about their
results. More information is available at www.orthoclinical.com. (AP)