Recall -- Firm Press Release
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Ortho-Clinical Diagnostics, Inc. Issues Voluntary, Nationwide Recall for Cardiac Marker
FOR IMMEDIATE RELEASE -- RARITAN, N.J., May 4 – 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® 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® 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 www.fda.gov/medwatch.