Class I Medical Device Recall - Ortho-Clinical Diagnostics, Inc. VITROS® Immunodiagnostic Products Troponin I Reagent Pack

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.

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.

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.

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.

For more information about this recall, please see the company’s press release at: http://www.orthoclinical.com/pressReleases.aspx?id=136

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 either online, by regular mail or by FAX.

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD
  20852-9787
• FAX: 1-800-FDA-0178