VITROS(R) Immunodiagnostic Products Troponin I Reagent Packs, Lots 3151 and
3170, CAT No. 194 9882
RARITAN, N.J., May 4 /PRNewswire/ -- Ortho-Clinical Diagnostics, Inc.
has initiated a voluntary, nationwide recall of two lots of a diagnostic
test used by physicians to aid in the diagnosis of injury to heart muscle
and/or heart attack because of shifts in test results that could contribute
to a missed diagnosis of myocardial infarction.
The company initiated the voluntary recall of the VITROS(R)
Immunodiagnostic Products Troponin I Reagent Pack, Lots 3151 and 3170,
after a small number of clinical laboratories administering the test
reported shifts in quality control results. An investigation by
Ortho-Clinical Diagnostics determined that the potential existed for false
negative troponin-I results at very low levels of troponin elevation. A
false negative test result would indicate that a person has not had a heart
attack or heart muscle injury when in fact they have. Ortho-Clinical
Diagnostics is working to identify the root cause of the reported issue.
The recall is limited to the VITROS(R) Immunodiagnostic Products
Troponin I Reagent Pack, Lots 3151 and 3170. Clinical labs in possession of
these lots have been contacted via phone, fax and overnight mail by the
company and instructed to (a) discontinue use of this product and (b)
notify healthcare providers who ordered the test in recent weeks. The
identified product lots were distributed to clinical labs in the United
States and outside the U.S. between January and March of 2007. Replacement
product has been provided to clinical labs with the affected product lots.
Ortho Clinical-Diagnostics has reported the action to the U.S. Food and
Drug Administration. No injuries have been reported to date.
A troponin I test is usually ordered, along with other cardiac tests,
in the hospital to determine if a patient has had a heart attack or injury
to heart muscle. The test, conducted using a sample of the patient's blood,
aids in the diagnosis of myocardial injury or infarction. The results of
troponin I tests should be used in conjunction with other diagnostic
information including other cardiac markers, ECG, clinical observations and
symptoms.
Clinical laboratories with questions may contact the company at
1-800-421-3311.
Any adverse reactions experienced with the use of this product, and/or
quality problems should also be reported to the FDA's MedWatch Program by
phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch,
HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch
website at http://www.fda.gov/medwatch.
About Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics, a Johnson & Johnson company, is a leading
provider of high-value diagnostic solutions for the global health care
community. Ortho-Clinical Diagnostics also provides blood screening and
typing products that help to ensure the safety of the world's blood supply.
For more information, visit http://www.orthoclinical.com.
SOURCE Ortho-Clinical Diagnostics, Inc.
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Related links:
http://www.orthoclinical.com
http://www.jnj.com http://www.fda.gov/medwatch
http://www.prnewswire.com/comp/467347.html /
CONTACT:
Steve Dnistrian, +1-908-218-8287, mobile:
+1-908-642-6047, for Ortho-Clinical Diagnostics
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