RARITAN, N.J., March 31 /PRNewswire/ -- Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson company, has initiated a nationwide voluntary product recall of a reagent used with its VITROS Immunodiagnostic ECi/ECiQ laboratory test system because the reagent may produce inaccurate tests results in some cases. This reagent is a special chemical used in the test system by laboratories to test patient samples.
The reagent being recalled is the VITROS(R) Immunodiagnostic Products Signal Reagent (SR), used on the VITROS Immunodiagnostics ECi/ECiQ System. The test system is used in clinical laboratories to screen for more than 40 diseases and conditions. This recall affects two of 50 lots of this reagent (or four percent) currently in distribution globally. One lot being recalled was distributed in the U.S., and one in countries outside the U.S.
Inaccurate test results may affect test outcomes in these critical areas: cardiac (heart attack); hepatitis (A, B or C); thyroid disorders; HIV and pregnancy. Patients who have had diagnostic testing performed for any of these medical conditions within the last 60 days and are concerned with their test results are recommended to discuss this matter with their physicians.
Ortho-Clinical Diagnostics has advised laboratories, using this reagent, to contact the patient’s physician if there are any concerns regarding previous test results.
This voluntary product recall includes: VITROS Signal Reagent, Lot 8350, catalog # 107 2693 VITROS Signal Reagent, Lot 8530, catalog # 107 2693.
Ortho-Clinical Diagnostics initiated a voluntary product recall by notifying all distributors and customers with a VITROS ECi/ECiQ System. Customers with the affected lots were asked to immediately discontinue using any remaining VITROS SR Lot 8350 or 8530 if alternate lots were in inventory and to follow an enhanced Quality Control (QC) procedure for all lots of VITROS Signal Reagent until further notice. This precautionary measure is designed to identify any potential packs of affected VITROS Signal Reagent.
Ortho-Clinical Diagnostics notified its customers and distributors by letter of this recall on March 28, 2006. The U.S. Food and Drug Administration was apprised of this action. No injuries have been reported to date. Customers with questions may contact the company at 1-800-421-3311.
Ortho-Clinical Diagnostics, a Johnson & Johnson company, is a leading provider of high-value diagnostic solutions for the global health care community. Committed to developing the most advanced tests for early detection or diagnosis of disease, the company brings products to market that provide timely information and help to facilitate better medical decisions. Ortho- Clinical Diagnostics also provides blood screening and typing products that help to ensure the safety of the world’s blood supply. In addition, through its VITROS MicroSlide(TM) and enhanced chemiluminescence technologies, the company has transformed the way that clinical laboratories perform testing. Worldwide, health care professionals rely on Ortho-Clinical Diagnostics for innovative diagnostic solutions and services that promote effective diagnoses and enhance patient care. For more information, visit www.orthoclinical.com.
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.
Ortho-Clinical Diagnostics, Inc.
CONTACT: Steve Dnistrian, Ortho-Clinical Diagnostics, Inc.,+1-908-218-8287, cell, +1-908-642-6047, sdnistri@ocdus.jnj.com
Web site: http://www.orthoclinical.com/
Company News On-Call: http://www.prnewswire.com/comp/467347.html /
