Navigation Links
Biosite Incorporated Issues Voluntary, Nationwide Recall for Cardiac Marker Test
Date:5/6/2009

SAN DIEGO, May 6 /PRNewswire/ -- Biosite Incorporated has initiated a voluntary, nationwide recall of one lot of Triage(R) Cardiac Panel. The test is used by healthcare professionals as an aid in the diagnosis of myocardial infarction (heart attack). The product has been recalled due to reports of low recovery of quality control samples containing Creatine Kinase MB (CK-MB), troponin I and myoglobin on the affected lot. Although there have been no reported issues of patient misdiagnosis associated with this lot to date, low recovery may lead to reporting of falsely low values for CK-MB, troponin I and myoglobin. A root cause investigation has been initiated.

The recall is limited to the Triage(R) Cardiac Panel, Catalog No. 97000HS, Lot #W44467B. Biosite Incorporated has notified its customers via overnight mail and has instructed them to discontinue use of the affected lot and discard any remaining product from the lot that is on hand. The identified lot was distributed to clinical labs in the United States between January and February 2009. Replacement product will be provided to clinical labs with remaining inventory of this affected product lot.

Biosite Incorporated has reported the action to the U.S. Food and Drug Administration.

As is noted in the package insert, the results of the Triage Cardiac Panel should not be used as absolute evidence of myocardial infarction and should be evaluated in the context of all the clinical and laboratory data available.

Customers with questions may contact the company at 1-877-441-7440, option 2 (24 hours a day, 7 days a week)

Any adverse reactions experienced with the use of this product, and/or quality problems can 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 '/>"/>

SOURCE Biosite Incorporated
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Abbey Spanier Rodd & Abrams, LLP, Announces Class Action Lawsuit on Behalf of Sequenom, Incorporated Shareholders
2. Accuray Incorporated to Report Financial Results for Third Quarter Fiscal Year 2009
3. Aflac Incorporated To Present at the Raymond James 30th Annual Institutional Investors Conference
4. Aflac Incorporated Provides Added Detail on Perpetual Debenture Holdings
5. Aflac Incorporated Announces Fourth Quarter Results, Sees 2008 RBC Ratio Above 450%, Affirms 2009 Operating EPS Target
6. Aflac Incorporated To Release Fourth Quarter Results on February 2, 2009
7. Accuray Incorporated to Present at 11th Annual Needham Growth Stock Conference
8. Aflac Incorporated To Present at the Goldman Sachs U.S. Financial Services Conference 2008
9. Accuray Incorporated to Present at 20th Annual Piper Jaffray Health Care Conference
10. Vertrue Incorporated Gives Tips on How to Hold a Health Fair
11. Accuray Incorporated Ranked Fifth in Deloittes Technology Fast 50 Program for Silicon Valley Scientific/Medical Equipment, and Biotechnology Companies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/27/2015)... The Willliams Companies Inc owns and operates ... The plant processes natural gas gathered from wells ... pipeline transport. It also produces natural gas liquids (NGLs) ... operations in 1958, and in recent decades has undergone ... Wyoming. The plant currently has approximately 40 employees. ...
(Date:2/27/2015)... Albany, NY (PRWEB) February 27, 2015 ... assessment report to its huge database of market studies ... devices market for the period of 2015-2019. The research ... future prospects of the sports medicine devices industry across ... “Global Sports Medicine Devices Market 2015-2019”, the global sports ...
(Date:2/27/2015)... (PRWEB) February 27, 2015 Dr. James Rybacki, ... by new data saying that 6 people die every day ... a new eBook to address the problem and help people ... on Alcohol has answers to the following questions:, ... Do you know what binge drinking is? , ...
(Date:2/27/2015)... Newport Beach, CA (PRWEB) February 27, 2015 ... following a facelift, is ignoring aftercare instructions. These ... and protect the investment you make. , “Investing time ... just as important as choosing the right plastic surgeon,” ... correlation between patients who achieve the highest and longest ...
(Date:2/26/2015)... (PRWEB) February 27, 2015 Guide to ... http://www.fdanews.com/GuideToFDAMDRegs2015 , Whether a manufacturers needs to ... a simple 510(k) filing or implement UDI across a ... regulatory professionals need. The most up-to-date, latest FDA regulations ... to FDA Medical Device Regulations is an FDAnews best-seller. ...
Breaking Medicine News(10 mins):Health News:Clean Water Systems Supplies Advanced Chlorine Disinfection Skid for Wyoming Gas Plant 2Health News:Global Sports Medicine Devices Market Benefitting from Significant Contribution from Arthroscopy Segment: MarketResearchReports.Biz 2Health News:Global Sports Medicine Devices Market Benefitting from Significant Contribution from Arthroscopy Segment: MarketResearchReports.Biz 3Health News:6 People Die Each Day From Alcohol Poisoning, new Essential Guide to Prescription Drugs eBook seeks to prevent interactions and deaths 2Health News:Gallery of Cosmetic Surgery Announces Tips for Protecting Your Plastic Surgery Investment 2Health News:FDAnews Bestseller Updated: Guide to FDA Medical Device Regulations — 2015 Edition 2
... New Facility to ... WASHINGTON, July 15 The Department of Veterans Affairs (VA) announced ... construct a new 80-bed acute psychiatric facility at VA,s Palo Alto Health Care ... war are visible," said Dr. Gerald Cross, VA,s Acting Under Secretary for Health. ...
... More long-term problems seen with minimally invasive technique ... originally designed for a completely different purpose has unearthed ... way that the vein used for the bypass is ... outcome of the surgery. , People whose veins are ...
... CLARA, Calif., July 15 Align Technology, Inc. (Nasdaq: ALGN ... its board of directors. Dr. Nagel will serve as a member ... Dr. Nagel also serves on the board of directors of Leapfrog Enterprises ... , "Dr. Nagel,s extensive technical knowledge and senior ...
... , PHILADELPHIA, July 15 Genetics researchers ... studying human illnesses -- a reference standard of deletions and duplications ... healthy persons, the study provides one of the deepest and broadest ... a new research tool for diagnosing and identifying genetic problems in ...
... of others is key to their self-image, study finds ... they might not want to admit it, what other ... adolescents, a new study confirms. , Previous research into ... information provided by teens themselves, but the authors of ...
... , IRVINE, Calif., July 15 In conjunction with CorVel Corporation,s (Nasdaq: ... broadcast live over the Internet on Tuesday, August 4th at 11:30 am Eastern Time. , ... CorVel Corporation Quarterly Earnings Release, Hosted by: Dan Starck, President and CEO, ... Clemons, Chairman, Date: 11:30 am Eastern Time, ...
Cached Medicine News:Health News:Vein Removal Method Linked to Bypass Results 2Health News:Vein Removal Method Linked to Bypass Results 3Health News:David Nagel Joins Align Technology Board of Directors 2Health News:New Map of Genomic Variation Will Enable Disease Research 2Health News:New Map of Genomic Variation Will Enable Disease Research 3Health News:New Map of Genomic Variation Will Enable Disease Research 4Health News:Younger Teens Really Do Care What People Think 2Health News:CorVel Announces Earnings Release Webcast 2
(Date:2/26/2015)... MILFORD, Mass. , Feb. 26, 2015 /PRNewswire/ ... developing novel therapeutics for the treatment of virus ... , CPA, has been appointed Vice President of ... be responsible for financial and administrative activities, including ... He reports to Douglas J. Jensen , ...
(Date:2/26/2015)... February 26, 2015 Vectorious ... cardiac monitoring system for patients suffering from congestive ... closed a $5 million financing round. Investors in ... owned jointly by Yehuda Zisapel and Prof. ... Gilon, Gur Muntzer and others; and the U.S.-based ...
(Date:2/26/2015)... Colo. , Feb. 26, 2015 ... installation Company specializing in commercial indoor cannabis cultivation ... continued evolution from start-up to fast-paced manufacturing and ... Tom Bollich , current Director and CEO, will ... "I,m extremely proud of what the team has ...
Breaking Medicine Technology:Jonathan P. Freve, CPA, Joins Spring Bank Pharmaceuticals as Vice President of Finance 2Vectorious Medical Technologies Completes $5M Raise 2Surna, Inc. Announces Senior Leadership Changes 2Surna, Inc. Announces Senior Leadership Changes 3Surna, Inc. Announces Senior Leadership Changes 4
... today launched a new program to help county residents deal ... with the National Association of Counties (NACo), the free Prescription ... offers an average of 24 percent savings off the retail ... be used by those who do not have insurance or ...
... Perrigo Company (Nasdaq: PRGO ; TASE) today ... quarter fiscal 2012 on Thursday, October 27, 2011 at approximately ... at 10:00 a.m. (ET) hosted by Joseph C. Papa, Perrigo,s ... will be available live via webcast to interested parties on ...
Cached Medicine Technology:Yamhill County Introduces Prescription Discount Card to Help Alleviate High Costs 2
... MDS display system provides maximum impact for ... This unique approach to displaying frames allows ... and create appealing, flexible and eye-catching displays. ... and your patients are motivated. Removable holders. ...
A pre-assembled, hexagonal, revolving tower display with two round 19.75" in diameter adjustable shelves. Enjoy 3.5 square feet of elegant shelf space for your products....
A pre-assembled, rectangular shadow box/wall hanging display. It have 3 adjustable shelves with tempered glass, four 50 watt halogen top lights, laminated deck, dust resistant and electrical cord wit...
Classic is proud to provide top-quality vision eyewear to physicians, health maintenance organizations (HMOs), and numerous state and federal government programs. Classic Laboratory produces over 150...
Medicine Products: