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U.S. Department of Health and Human Services

Medical Devices

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Ortho-Clinical Diagnostics, Inc. VITROS® Immunodiagnostic Products Troponin I Reagent Pack

Class 1 Recall
Date Recall
Initiated
April 27, 2007
Product:

Ortho-Clinical Diagnostics, Inc. VITROS® Immunodiagnostic Products, Troponin I Reagent Packs, Lots 3151 and 3170 (Catalog No. 1949882). Affected lots were manufactured between January 5, 2007 and February 1, 2007 and distributed between January, 2007 and March, 2007.

 

Use:

Doctors use this test in diagnosing damage to the heart and/or a heart attack (myocardial infarction) in people who have had chest pain.

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 damage to the heart muscle. The test is conducted using a sample of the patient’s blood. The results of troponin I test should be used with additional medical tests and medical information including other cardiac markers, electrocardiogram (ECG), medical observations, and symptoms to determine if the patient has had a heart attack, or is experiencing chest pain due to other causes.

 

Recalling Firm:

Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, New York 14626-5101

 

Reason for Recall:

A small number of clinical laboratories analyzing the test reported inconsistent quality of test results, including false negative results. A false negative test result would show no evidence of a heart attack or damage to the heart muscle in a person who did have a heart attack. Ortho-Clinical Diagnostics determined that there is the potential for the VITROS® Immunodiagnostic Products, Troponin I test to show false negative troponin I results at very low levels of troponin elevation.

Patients who have had this test since January 2007 should contact their doctor if they have any concerns about the results of their test.

 

Public Contact:
Clinical laboratories can call the company at 1-800-421-3311.
FDA District:
New York
FDA Comment:

The company contacted U.S. labs using the affected lot numbers via phone, fax and overnight mail and foreign labs contacted by e-mail. The labs have been instructed to (a) discontinue use of this product and (b) notify healthcare providers who ordered the test in recent weeks. Replacement products have been provided to clinical labs with the affected product lots.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that, should this particular malfunction occur, use of the affected product may cause serious injury or death if the problem is not corrected.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program. See the nearby link to MedWatch.