News | May 06, 2007

Ortho-Clinical Diagnostics Recalls Heart Attack Tests

May 7, 2007 — 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 FDA. No injuries have been reported to date.

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 Web site at

For more information about Ortho-Clinical Diagnostics visit

Related Content

Siemens Healthineers to Acquire Epocal from Alere
News | Point of Care Testing | July 26, 2017
Siemens Healthineers has entered into a definitive agreement to acquire Epocal Inc., a subsidiary of Alere Inc. Epocal...
Alere point of care POC testing for INR
News | Point of Care Testing | July 17, 2017 | Dave Fornell
July 17, 2017 — Despite issues with point-of-care INR testing company Alere Inc., Abbott announced this week it is on
Siemens Xprecia Stride anticoagulation, coagulation PT/INR or INR testing at the point of care (POC)

Point-of-care coagulation PT/INR testing with handheld devices can help improve outcomes with more convenient and frequent measurements to keep patients within the therapeutic range of anticoagulant agents.

Feature | Point of Care Testing | May 05, 2017 | Nicholas C. Vanderslice, Ph.D., and Arnol S. Rios
Point-of-care (POC) coagulation analyzers that measure prothrombin time/international normalized ratio (PT/INR) on fi
HyperMed Imaging, HyperView portable tissue oxygenation measurement system, FDA clearance
Technology | Point of Care Testing | January 27, 2017
HyperMed Imaging Inc. announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the...

The Xprecia Stride Coagulation Analyzer delivers fast, reliable prothrombin time/international normalized ratio (PT/INR) testing for point-of-care monitoring and management of oral anticoagulation therapy with warfarin, a vitamin K antagonist. It is the latest INR testing system to enter the market in late 2016. Read the article “Siemens Receives FDA Clearance of Xprecia Stride Coagulation Analyzer.”


Feature | Point of Care Testing | December 30, 2016 | Ravi Chawat
Point of care testing devices are gaining widespread approval for prompt medical diagnoses, especially in cardiology
INRatio, Alere, Abbott, I and R testing, INR testing
Feature | Point of Care Testing | December 07, 2016
December 7, 2016 — Abbott has filed a complaint to terminate its proposed acquisition of Alere based on the substanti
Siemens, FDA clearance, Xprecia Stride Coagulation Analyzer, point-of-care testing
Technology | Point of Care Testing | November 10, 2016
Siemens Healthineers announced U.S. Food and Drug Administration (FDA) 510(k) clearance for a hand-held portable...
Abbott, Alere, acquisition, point of care diagnostics
News | Point of Care Testing | February 03, 2016
Abbott and Alere Inc. announced a definitive agreement for Abbott to acquire Alere. Under the terms of the agreement,...
News | Point of Care Testing | December 22, 2015
Trinity Biotech plc announced submission of its Meritas Point of Care Analyzer and Meritas cardiac troponin-I (cTnI)...
The Lancet results, Abbott ARCHITECT STAT High Sensitive Troponin-I test, rule out myocardial infarction, Accident and Emergency, A&E
News | Point of Care Testing | October 13, 2015
The Lancet published results online that show Abbott’s ARCHITECT STAT High Sensitive Troponin-I (hsTnl) test may rule...
Overlay Init